Discussion:
MS society Canada-- oral medication versus injectables
(too old to reply)
white lynx
2006-09-18 21:57:25 UTC
Permalink
I think this is what they were talking about on the TV news
they said on the TV program/news it reduced plaques on the brain
significantly more than placebo and even more then the common ABC
injectables

You can go on the MS society web page to look at other research news
http://www.mssociety.ca/en/research/medmmo_fingolimod_20060822.htm

Larry
rather than building character, adversity is more likely to reveal it
written with voice recognition software and a magic wand

Update Memo
August 22, 2006
Investigators are seeking participants with relapsing-remitting MS for a
large, international phase III clinical trial to evaluate the
effectiveness and safety of a potential oral MS therapy, known as
fingolimod or FTY720.

The study called FREEDOMS, (FTY720 Research Evaluation Daily Oral
efficacy in MS), will last 24 months and compare two dosage levels of
fingolimod to placebo. Approximately 1,250 people with
relapsing-remitting MS will participate at 125 centres worldwide,
including 10 in Canada. The study is sponsored by Novartis.

The study will include people with relapsing-remitting MS between the
ages of 18 and 55 who have experienced at least one relapse during the
past year, or two relapses in the past two years and meet the study
eligibility criteria.

Results from a previous smaller study found after six months of
treatment, that fingolimod reduced the rate of clinical relapses by more
than 50 percent and reduced inflammatory activity as measured by MRI by
up to 80 percent compared to placebo.

For more information about the study, please call 1-866-788-3930 or
contact one of the participating Canadian clinical trial sites listed
below. You can also visit www.clinicaltrials.gov (U.S. government
website; English only) or www.MSClinicalTrials.com (Novartis website;
English only). Some of the study sites will be using Internet-based
recruitment, starting in September 2006. Information about the
e-recruitment process will be provided when it is available.

Canadian clinical trial sites
St. Michael's Hospital, Toronto, Dr. Paul O'Connor, 416-864-5830

University of British Columbia, Vancouver, Wendy Morrison, Study
Coordinator, 604-822-1756

Kingston General Hospital, MS Clinic, Kingston, Dr. Donald G. Brunet or
Vee McBride 613-548-2308

University of Saskatchewan, Regina, Felix Veloso, Principal Investigator
306-525-3586

Dalhousie University, MS Research Unit, Halifax, Trudy L. Campbell,
902-473-7947

University of Calgary, MS Clinical Research Program, Calgary, Janet
Moores, Study Coordinator, 403-944-1802

Nepean Medical Centre, Ottawa, Isabelle D. Bedirian, Clinical Trials
Coordinator, 613-224-1223

Health Sciences Centre, Winnipeg, Dr. Maria Melanson, 204-787-4778

ASK MS Information System Code: 1.4.1.75.a

National Research Department
National Marketing and Communications Department



Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary
health agency and does not approve, endorse or recommend any specific
product or therapy but provides information to assist individuals in
making their own decisions.

Back to top

Multiple Sclerosis Society of Canada
Toll free to reach nearest division office: 1 800 268-7582

To locate the MS Society office near you, please select the appropriate
division:

Select Division: British Columbia Division Alberta Division
Saskatchewan Division Manitoba Division Ontario Division Quebec Division
Atlantic Division

Email: click here ***@mssociety.ca
(Please provide your town and province in your email)

© 2005 Multiple Sclerosis Society of Canada



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Peace Dove
2006-09-18 22:16:08 UTC
Permalink
Thank you for going to this trouble Larry - I hope this new research
will show this oral med to be helpful --- I wish you all good things -
happy to see you posting more -- .... Dove
Rue Hesterly
2006-09-19 01:13:06 UTC
Permalink
Larry,
Thank You so much for posting this information. I have had nothing but
problems with injectables. Maybe IF this gets approved, I could finally have
a slowing of this ppms. <DIV>&quot;white lynx&quot; &lt;***@shaw.ca&gt; wrote in message news:9DEPg.566867$***@pd7tw1no...</DIV>>I think this is what they were
talking about on the TV news
Post by white lynx
they said on the TV program/news it reduced plaques on the brain
significantly more than placebo and even more then the common ABC
injectables
You can go on the MS society web page to look at other research news
http://www.mssociety.ca/en/research/medmmo_fingolimod_20060822.htm
Larry
Jennifer
2006-09-19 03:38:10 UTC
Permalink
my neuro is involved in this and when I talked with him last Jan (I only see
him for yearly appointments) he was quite excited about this.

Though I don't meet the criteria, I'm interested in the outcome

Jen
Post by white lynx
I think this is what they were talking about on the TV news
they said on the TV program/news it reduced plaques on the brain
significantly more than placebo and even more then the common ABC
injectables
You can go on the MS society web page to look at other research news
http://www.mssociety.ca/en/research/medmmo_fingolimod_20060822.htm
Larry
rather than building character, adversity is more likely to reveal it
written with voice recognition software and a magic wand
Update Memo
August 22, 2006
Investigators are seeking participants with relapsing-remitting MS for a
large, international phase III clinical trial to evaluate the
effectiveness and safety of a potential oral MS therapy, known as
fingolimod or FTY720.
The study called FREEDOMS, (FTY720 Research Evaluation Daily Oral
efficacy in MS), will last 24 months and compare two dosage levels of
fingolimod to placebo. Approximately 1,250 people with
relapsing-remitting MS will participate at 125 centres worldwide,
including 10 in Canada. The study is sponsored by Novartis.
The study will include people with relapsing-remitting MS between the
ages of 18 and 55 who have experienced at least one relapse during the
past year, or two relapses in the past two years and meet the study
eligibility criteria.
Results from a previous smaller study found after six months of
treatment, that fingolimod reduced the rate of clinical relapses by more
than 50 percent and reduced inflammatory activity as measured by MRI by
up to 80 percent compared to placebo.
For more information about the study, please call 1-866-788-3930 or
contact one of the participating Canadian clinical trial sites listed
below. You can also visit www.clinicaltrials.gov (U.S. government
website; English only) or www.MSClinicalTrials.com (Novartis website;
English only). Some of the study sites will be using Internet-based
recruitment, starting in September 2006. Information about the
e-recruitment process will be provided when it is available.
Canadian clinical trial sites
St. Michael's Hospital, Toronto, Dr. Paul O'Connor, 416-864-5830
University of British Columbia, Vancouver, Wendy Morrison, Study
Coordinator, 604-822-1756
Kingston General Hospital, MS Clinic, Kingston, Dr. Donald G. Brunet or
Vee McBride 613-548-2308
University of Saskatchewan, Regina, Felix Veloso, Principal Investigator
306-525-3586
Dalhousie University, MS Research Unit, Halifax, Trudy L. Campbell,
902-473-7947
University of Calgary, MS Clinical Research Program, Calgary, Janet
Moores, Study Coordinator, 403-944-1802
Nepean Medical Centre, Ottawa, Isabelle D. Bedirian, Clinical Trials
Coordinator, 613-224-1223
Health Sciences Centre, Winnipeg, Dr. Maria Melanson, 204-787-4778
ASK MS Information System Code: 1.4.1.75.a
National Research Department
National Marketing and Communications Department
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary
health agency and does not approve, endorse or recommend any specific
product or therapy but provides information to assist individuals in
making their own decisions.
Back to top
Multiple Sclerosis Society of Canada
Toll free to reach nearest division office: 1 800 268-7582
To locate the MS Society office near you, please select the appropriate
Select Division: British Columbia Division Alberta Division
Saskatchewan Division Manitoba Division Ontario Division Quebec Division
Atlantic Division
(Please provide your town and province in your email)
© 2005 Multiple Sclerosis Society of Canada
Multiple Sclerosis Support & Services Research Treatments Donate
Now Get Involved Special Events
Home About Us Media Contact Us Site Map Privacy Français
Jack N Dalton
2006-09-22 08:40:55 UTC
Permalink
Weapon against MS: Transplant drug limits nerve damage
Nathan Seppa

A drug originally devised to prevent immune rejection of organ transplants
can lessen relapses in patients with multiple sclerosis, a new study finds.

The drug, called fingolimod, inhibits immune cells from destroying the fatty
coatings of nerve fibers in the brain and spinal cord. Damage of such myelin
sheaths leads to multiple sclerosis (MS) symptoms, which include fatigue,
balance problems, and loss of muscle control.

Although preliminary, the study is the second piece of welcome news this
year for MS patients. Citing new findings of the effectiveness and safety of
the drug natalizumab (Tysabri), the Food and Drug Administration in June
reinstated it for some MS patients. The agency had approved the drug in
2004, but sales were halted for safety reasons.

In the latest study, researchers in Europe and Canada gave a daily
fingolimod pill to 160 MS patients. Half the recipients got a dose four
times as high as the dose that the others received. Another group of 81
patients received inert pills.

All the patients saw a doctor regularly and underwent monthly magnetic
resonance imaging (MRI) to detect myelin-sheath damage in the brain or
spinal cord. The doctors didn't know which patients were receiving doses of
the drug or the placebo.

Over 6 months, patients getting either drug dose were less than half as
likely as the placebo patients to relapse, either developing new or stronger
MS symptoms, says study coauthor Ludwig Kappos, a neurologist at the
University Hospital Basel in Switzerland. MRI scans during that time
revealed that patients getting the drug had fewer new sites of myelin damage
than the participants receiving the placebo had.

After 6 months, the patients getting the placebo were switched to one of the
fingolimod doses. Over 6 more months, most of those people had fewer
relapses and fewer sites of new myelin damage than they had while receiving
the placebo, the scientists report in the Sept. 14 New England Journal of
Medicine (NEJM).

Fingolimod suppresses immunity. People taking the higher dose were more
likely than those in the other groups to get upper respiratory infections,
the researchers say.

Fingolimod appears to work by snagging newly minted immune cells that target
myelin in the central nervous system and sequestering them in lymph nodes,
pathologists Steffen Massberg and Ulrich von Andrian of Harvard Medical
School in Boston say in the NEJM carrying the new study.

"These data are impressive," says Peter A. Calabresi, a neurologist at Johns
Hopkins Medical Institutions in Baltimore. Judging from this study,
fingolimod may hold off relapses better than do common MS drugs such as
interferon. Only natalizumab, which is injected monthly, has performed
better in tests, says Calabresi, who acknowledges that he has consulted for
Novartis, the Switzerland-based manufacturer that makes fingolimod and
funded the new study.

Effectiveness aside, fingolimod's real advantage might be that it's a pill,
Calabresi says. "All the other drugs we have on the market are injectable
therapies," he notes.

Two longer-term studies with more participants are under way, Kappos says.
One is testing fingolimod against interferon beta-1a injections, and the
other is another comparison with a placebo.
Post by white lynx
I think this is what they were talking about on the TV news
they said on the TV program/news it reduced plaques on the brain
significantly more than placebo and even more then the common ABC
injectables
You can go on the MS society web page to look at other research news
http://www.mssociety.ca/en/research/medmmo_fingolimod_20060822.htm
Larry
rather than building character, adversity is more likely to reveal it
written with voice recognition software and a magic wand
Update Memo
August 22, 2006
Investigators are seeking participants with relapsing-remitting MS for a
large, international phase III clinical trial to evaluate the
effectiveness and safety of a potential oral MS therapy, known as
fingolimod or FTY720.
The study called FREEDOMS, (FTY720 Research Evaluation Daily Oral efficacy
in MS), will last 24 months and compare two dosage levels of fingolimod to
placebo. Approximately 1,250 people with relapsing-remitting MS will
participate at 125 centres worldwide, including 10 in Canada. The study is
sponsored by Novartis.
The study will include people with relapsing-remitting MS between the ages
of 18 and 55 who have experienced at least one relapse during the past
year, or two relapses in the past two years and meet the study eligibility
criteria.
Results from a previous smaller study found after six months of treatment,
that fingolimod reduced the rate of clinical relapses by more than 50
percent and reduced inflammatory activity as measured by MRI by up to 80
percent compared to placebo.
For more information about the study, please call 1-866-788-3930 or
contact one of the participating Canadian clinical trial sites listed
below. You can also visit www.clinicaltrials.gov (U.S. government website;
English only) or www.MSClinicalTrials.com (Novartis website; English
only). Some of the study sites will be using Internet-based recruitment,
starting in September 2006. Information about the e-recruitment process
will be provided when it is available.
Canadian clinical trial sites
St. Michael's Hospital, Toronto, Dr. Paul O'Connor, 416-864-5830
University of British Columbia, Vancouver, Wendy Morrison, Study
Coordinator, 604-822-1756
Kingston General Hospital, MS Clinic, Kingston, Dr. Donald G. Brunet or
Vee McBride 613-548-2308
University of Saskatchewan, Regina, Felix Veloso, Principal Investigator
306-525-3586
Dalhousie University, MS Research Unit, Halifax, Trudy L. Campbell,
902-473-7947
University of Calgary, MS Clinical Research Program, Calgary, Janet
Moores, Study Coordinator, 403-944-1802
Nepean Medical Centre, Ottawa, Isabelle D. Bedirian, Clinical Trials
Coordinator, 613-224-1223
Health Sciences Centre, Winnipeg, Dr. Maria Melanson, 204-787-4778
ASK MS Information System Code: 1.4.1.75.a
National Research Department
National Marketing and Communications Department
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary
health agency and does not approve, endorse or recommend any specific
product or therapy but provides information to assist individuals in
making their own decisions.
Back to top
Multiple Sclerosis Society of Canada
Toll free to reach nearest division office: 1 800 268-7582
To locate the MS Society office near you, please select the appropriate
Select Division: British Columbia Division Alberta Division Saskatchewan
Division Manitoba Division Ontario Division Quebec Division Atlantic
Division
(Please provide your town and province in your email)
© 2005 Multiple Sclerosis Society of Canada
Multiple Sclerosis Support & Services Research Treatments Donate
Now Get Involved Special Events
Home About Us Media Contact Us Site Map Privacy Français
Jane
2006-09-29 16:50:41 UTC
Permalink
Hi all,
I am usually a lurker here, but my new neurologist gave me some
paperwork on Fingolimod. She's an investigator in the next part of the
study, and she offered me the opportunity to participate. But I'm not
sure. Have any of you tried it yet? What do you think about it? Is
it worth it?

Here's the deal. There are three groups: one gets 1.25 mg, one gets .5
mg and one gets placebo. No one knows which group a given individual
is in. The original study of Fingolimod didn't have a .5 mg, they use
5 mg! Everyone in the study gets vision tests, heart tests and lung
tests. Everyone also gets "High Resolution Comupter Tomography" of the
chest a couple of times. And tons of MRIs. And tests, tests, and
more tests.

I THINK I was originally diagnosed as relapsing-remitting, but then my
second neuro classified me as primary progressive, and my new one
classified me as secondary progressive. I know that this capsule is
meant for relapsing-remitting. I did have an exacerbation a couple of
months ago; it was the first in easily 3 or 4 (maybe even 5) years.

I love the idea of the complete "picture" that they'll get about my
body, but I'm just not sure how I feel about being the 282nd patient to
try it (I understand that there will be 960 participants, so I may end
up being the 960th person to try it). Any suggestions?

Thanks,
Jane
Post by Jack N Dalton
Weapon against MS: Transplant drug limits nerve damage
Nathan Seppa
A drug originally devised to prevent immune rejection of organ transplants
can lessen relapses in patients with multiple sclerosis, a new study finds.
The drug, called fingolimod, inhibits immune cells from destroying the fatty
coatings of nerve fibers in the brain and spinal cord. Damage of such myelin
sheaths leads to multiple sclerosis (MS) symptoms, which include fatigue,
balance problems, and loss of muscle control.
Although preliminary, the study is the second piece of welcome news this
year for MS patients. Citing new findings of the effectiveness and safety of
the drug natalizumab (Tysabri), the Food and Drug Administration in June
reinstated it for some MS patients. The agency had approved the drug in
2004, but sales were halted for safety reasons.
In the latest study, researchers in Europe and Canada gave a daily
fingolimod pill to 160 MS patients. Half the recipients got a dose four
times as high as the dose that the others received. Another group of 81
patients received inert pills.
All the patients saw a doctor regularly and underwent monthly magnetic
resonance imaging (MRI) to detect myelin-sheath damage in the brain or
spinal cord. The doctors didn't know which patients were receiving doses of
the drug or the placebo.
Over 6 months, patients getting either drug dose were less than half as
likely as the placebo patients to relapse, either developing new or stronger
MS symptoms, says study coauthor Ludwig Kappos, a neurologist at the
University Hospital Basel in Switzerland. MRI scans during that time
revealed that patients getting the drug had fewer new sites of myelin damage
than the participants receiving the placebo had.
After 6 months, the patients getting the placebo were switched to one of the
fingolimod doses. Over 6 more months, most of those people had fewer
relapses and fewer sites of new myelin damage than they had while receiving
the placebo, the scientists report in the Sept. 14 New England Journal of
Medicine (NEJM).
Fingolimod suppresses immunity. People taking the higher dose were more
likely than those in the other groups to get upper respiratory infections,
the researchers say.
Fingolimod appears to work by snagging newly minted immune cells that target
myelin in the central nervous system and sequestering them in lymph nodes,
pathologists Steffen Massberg and Ulrich von Andrian of Harvard Medical
School in Boston say in the NEJM carrying the new study.
"These data are impressive," says Peter A. Calabresi, a neurologist at Johns
Hopkins Medical Institutions in Baltimore. Judging from this study,
fingolimod may hold off relapses better than do common MS drugs such as
interferon. Only natalizumab, which is injected monthly, has performed
better in tests, says Calabresi, who acknowledges that he has consulted for
Novartis, the Switzerland-based manufacturer that makes fingolimod and
funded the new study.
Effectiveness aside, fingolimod's real advantage might be that it's a pill,
Calabresi says. "All the other drugs we have on the market are injectable
therapies," he notes.
Two longer-term studies with more participants are under way, Kappos says.
One is testing fingolimod against interferon beta-1a injections, and the
other is another comparison with a placebo.
white lynx
2006-09-29 22:24:08 UTC
Permalink
the short answer is -- no

about six or seven years ago I entered the clinical trial test for a new
drug that did not work and the trial was called off after the first year

I really liked that my body had a very extensive check up.

I knew another person in the drug trial and we both felt the same -- we
were not looking for miracles for ourselves but felt that while we were
still mobile and healthy (we both were secondary progressive and could
walk approximately 20 yards with canes or crutches) that this was a
right time in our disease progression to still be active enough to
attend our appointments without exception and they still were enough
things working that did that she might make a difference for us.

We also knew another person in about the same situation whose reason for
participation in a trial program was a desperate grasp for a miracle.
This is a wrong reason for entering the drug trial in my opinion and in
the opinion of the other person who felt like I did.

We participated, not so much for ourselves, as we felt we had an
obligation to other people with the disease that this may help. If that
is the approach you take you will not be disappointed.

I ended up seeing the best heart specialist in British Columbia and had
my lungs very thoroughly checked out. The pharmaceutical companies want
to know for sure about existing conditions so that future developments
can be blamed on pre-existing conditions instead of on their product.

The MS clinic was quite specific in warning people that they could get
placebo in which case their disease could progress because they were not
taking any medication other than through the trial.

Financially it is a good deal but a gamble. You may end up on placebo
and of course you always have to consider all the possible side effects
the previous trials have identified.

I am very happy I participated when I did because I no longer would be
able to have one MRI a month because I can not get onto the bed by
myself in the hospital did not have the necessary mechanical lifts to
put me on the table.

I do know that I had quit smoking a few years before that but I was a
very heavy smoker -- I smoked 2 1/2 packages a day of 25 cigarettes for
more than 20 years. It was nice to know there was no permanent
damage.it is now about 20 years since I quit smoking and consider myself
lucky and note that if I just had a couple of cigarettes in the bar for
one or two nights I would be back to a pack a day by the end of the week.

It is a decision you should discuss with your doctor and carefully
consider the balance between possible good from the drug versus the
possible side effects and the possibility that you will be receiving
placebo and what that means for your disease progression.

At the time I was involved the ABC drugs were not out yet. I've
progressed too quickly to benefit from them and so only take drugs for
specific symptoms rather than trying to modify the disease. Of course
there would be no ABC drugs if someone did not volunteer for the drug
trials. I currently am of the feeling that after I finished that trial
I had done my part to help research on the disease and that it was too
much work and time for me to participate more than once.

If I was back at that stage when I participated in the past and the
opportunity came up to do this particular drug I would do it. Not for
me as much as for future generations.

We all have to make our own decisions and in some cases it would not be
worth the risk of side effects or taking no drugs or the expenditure of
energy and time when we were already quite exhausted from our mobility
difficulties and work responsibilities.

Sorry for going on so much, but these are things you should perhaps
consider.

Larry
rather than building character, adversity is more likely to reveal it
written with voice recognition software and a magic wand
rose
2006-09-30 15:17:07 UTC
Permalink
Post by white lynx
We participated, not so much for ourselves, as we felt we had an
obligation to other people with the disease that this may help. If that
is the approach you take you will not be disappointed.
Larry, I did a lot of clinical trials back when I was RR, working, and
insured, for just that reason. I was in pretty decent shape at the
time, physically and financially, and had not yet begun using clinical
trials as a way to obtain services I'd have been unable to afford
otherwise.

Maybe ironically, that IS why I'm wondering about whether she should
participate in the trial: a person who is either PPMS or SPMS most
likely *won't* be having relapses, with or without the drug. If a few
PP or SP folks are included, it has the potential to skew the results
from the trial: Look at all the people who did not relapse while they
were taking it! Me, I haven't had a relapse in six years -- LOL, if I
got into an RRMS-focused study, I'd be one of their "stars!" Check her
out -- she hasn't had a relapse since 2000, the drug obviously works.

I'd read that the Betaseron results were slightly skewed for just that
reason -- newer research has revealed that some of the original study
folks were "on the verge" of moving from RR to SP, and thus, their
relapses were sporadic even before beginning the therapy. They've now
decided that maybe, possibly, perhaps there's no such thing as "SPMS
with superimposed relapses" -- it's just that as one moves from RR to
SP, one has a few relapses along the way, before they cease completely.

I'm not so much down on the CRABs, as I am "down on" people for whom
the drugs will most likely have little to no effect, breaking
themselves financially, because they hear "Betaseron is the only
therapy effective with SPMS!" You know, it just really *isn't*. I think
neuros, at leat in the U.S., really do push their M.S. patients to be
on one of the CRABs, even their SPMS patients, because then both doctor
and patient can feel like "at least we've tried everything." Now, if it
was some cheapo substance, sure, try everything. But $1-2K per month,
for a lot of us, is simply unattainable, and for many others, ponying
up for the CRABs is financially draining. My own decision was, since
there's little to no chance these things are really doing anything re
disease progression, and since I don't *have* relapses, there are much
better ways to spend the bucks, that would improve my and my family's
quality of life a lot more than injecting Copaxone simply because my
neuro and I want to "feel like" we're doing something.

I *am* doing something -- living with as much joy and dignity as is
possible, making smaller-scale contributions than previously, but still
contributions, hangin' with the folks, just living the life I've got.
Oh yeah, and then there's the Novantrone thing, of course. ;->

Those who've noticed a dramatic improvement while on any M.S. drug,
good on 'em and I hope it continues! But for those of us who didn't
notice anything much, but whose docs pressure us to take "something,
anything" -- remember, it's YOUR decision. You know your health, your
life, and your financial sitch better than your neurologist does.
Listen to the doc and look at the research, of course -- then make the
decision that will be best for *you*. Don't rush in. Some docs will
tell you "the sooner the better" and encourage you to make your choice
ASAP. You know, a few months really ain't gonna make a difference --
take your time, think it out, then decide. Don't let the doc rush you.
It's his/her patient load, it's YOUR life, you're the one who *should*
be making the decision.

RD
Jane
2006-09-30 19:07:16 UTC
Permalink
Rose, I do understand what you're saying about someone who is PPMS or
SPMS, and has been offered to participate in this study, which is meant
for RRMS. I had been wondering the same thing. [I THINK my doctor
isn't sure of my diagnosis. As I think I said, I've been diagnosed as
all three basically at the same time (within a year, with no changes in
my disease). I have had an exacerbation recently, and I haven't been
on any of the CRABs for more than two years.] But I will discuss it
with my doctor! That really is an important point, and thank you for
making it.

I think it's also important for me to point out that I'm 53, and the
cutoff for this study (and others, I would guess) is 55. Also, I'm on
Medicare with AARP supplement. For that reason I like all the
additional testing that will be done at no cost to me.

I also like this neurologist and her office. Not necessarily her
personality, but the way she does business. She has never pushed the
CRABs on me. She has sent me for a number of studies: a sleep study,
a neuropsych exam, and another that I can't remember right off the bat.
When I had the exacerbation, her nurse-practitioner saw me the same
day!

Larry, thanks for your input as well. While I'm looking for myself to
not get any worse, I am really concerned about this RRMS/PPMS/SPMS
stuff. I know that I could end up on the placebo, but that would put me
no worse than I am now, since I don't take anything for my MS. (I do
take Klonopin, Zanaflex, Flexeril and Detrol for MS symptoms though.)
I know that I have been VERY lucky with my MS. I know people in
wheelchairs, walkers, AFOs, scooters, canes, basically anything you can
think of. (I know I'm leaving lots of stuff out.)

And I do understand that while I may or may not get any benefits from
this study, it does have the potential to be very helpful to others.
That is another reason I'd like to participate.

OK, so now I'm at the point where I'm going to talk to my neuro about
whether I should participate in this RRMS study, since she diagnosed me
as SPMS. And of course I need more info about the negative effects.

Anything else anyone can think of?

Thanks,
Jane
Post by rose
Post by white lynx
We participated, not so much for ourselves, as we felt we had an
obligation to other people with the disease that this may help. If that
is the approach you take you will not be disappointed.
Larry, I did a lot of clinical trials back when I was RR, working, and
insured, for just that reason. I was in pretty decent shape at the
time, physically and financially, and had not yet begun using clinical
trials as a way to obtain services I'd have been unable to afford
otherwise.
Maybe ironically, that IS why I'm wondering about whether she should
participate in the trial: a person who is either PPMS or SPMS most
likely *won't* be having relapses, with or without the drug. If a few
PP or SP folks are included, it has the potential to skew the results
from the trial: Look at all the people who did not relapse while they
were taking it! Me, I haven't had a relapse in six years -- LOL, if I
got into an RRMS-focused study, I'd be one of their "stars!" Check her
out -- she hasn't had a relapse since 2000, the drug obviously works.
I'd read that the Betaseron results were slightly skewed for just that
reason -- newer research has revealed that some of the original study
folks were "on the verge" of moving from RR to SP, and thus, their
relapses were sporadic even before beginning the therapy. They've now
decided that maybe, possibly, perhaps there's no such thing as "SPMS
with superimposed relapses" -- it's just that as one moves from RR to
SP, one has a few relapses along the way, before they cease completely.
I'm not so much down on the CRABs, as I am "down on" people for whom
the drugs will most likely have little to no effect, breaking
themselves financially, because they hear "Betaseron is the only
therapy effective with SPMS!" You know, it just really *isn't*. I think
neuros, at leat in the U.S., really do push their M.S. patients to be
on one of the CRABs, even their SPMS patients, because then both doctor
and patient can feel like "at least we've tried everything." Now, if it
was some cheapo substance, sure, try everything. But $1-2K per month,
for a lot of us, is simply unattainable, and for many others, ponying
up for the CRABs is financially draining. My own decision was, since
there's little to no chance these things are really doing anything re
disease progression, and since I don't *have* relapses, there are much
better ways to spend the bucks, that would improve my and my family's
quality of life a lot more than injecting Copaxone simply because my
neuro and I want to "feel like" we're doing something.
I *am* doing something -- living with as much joy and dignity as is
possible, making smaller-scale contributions than previously, but still
contributions, hangin' with the folks, just living the life I've got.
Oh yeah, and then there's the Novantrone thing, of course. ;->
Those who've noticed a dramatic improvement while on any M.S. drug,
good on 'em and I hope it continues! But for those of us who didn't
notice anything much, but whose docs pressure us to take "something,
anything" -- remember, it's YOUR decision. You know your health, your
life, and your financial sitch better than your neurologist does.
Listen to the doc and look at the research, of course -- then make the
decision that will be best for *you*. Don't rush in. Some docs will
tell you "the sooner the better" and encourage you to make your choice
ASAP. You know, a few months really ain't gonna make a difference --
take your time, think it out, then decide. Don't let the doc rush you.
It's his/her patient load, it's YOUR life, you're the one who *should*
be making the decision.
RD
rose
2006-10-01 18:20:18 UTC
Permalink
Post by Jane
Rose, I do understand what you're saying about someone who is PPMS or
SPMS, and has been offered to participate in this study, which is meant
for RRMS. I had been wondering the same thing. [I THINK my doctor
isn't sure of my diagnosis. As I think I said, I've been diagnosed as
all three basically at the same time (within a year, with no changes in
my disease). I have had an exacerbation recently, and I haven't been
on any of the CRABs for more than two years.] But I will discuss it
with my doctor! That really is an important point, and thank you for
making it.
HI Jane, and ACK! I just realized, reading through the thread, that I
was talking *about* you to Larry, rather than talking *to* you, and I
apologize for that. It's nice to 'meet' you, even though the
circumstances are way less than optimal!

I noticed in the study regulations, that they say they're looking for
people who have had a relapse within the last year, and you *have* had
one recently -- which would seem to preclude your being PPMS, since no
relapses/no remissions is the rule for Primary Progressive. The RR/SP
thing can be understandably confusing, even to professionals, as it's
more a process than a wham-bam-you're-SP-now-Ma'am thing. SPMS folks
start out as RRMS folks, and there are often relapses and remissions as
one moves closer to Secondary Progression. I didn't *want* to accept
the neuro's diagnostic change to SP at the time he made it, and went,
frankly, a little bit crazy trying to "prove" -- to him, to myself --
that I wasn't really SP; walking for miles every day, doing a lot of
active stuff, like "Ha! could someone with SPMS do *that!?" Heh, the
thing that finally convinced me was simply that after my last relapse
in 2000, I haven't had another one, and yet the disability progression
has become increasingly obvious. It's been long enough now that I'm
kinda-sorta-most-of-the-time at something like peace with it. When I
have a spazzy day like I had yesterday, the acceptance tends to get a
lot less "peaceful!" But then, I reckon we've *all* got our better days
and our worse days, including healthy, able-bodied people.
Post by Jane
I think it's also important for me to point out that I'm 53, and the
cutoff for this study (and others, I would guess) is 55. Also, I'm on
Medicare with AARP supplement. For that reason I like all the
additional testing that will be done at no cost to me.
I definitely hear you. When first diagnosed, I was employed and
insured, but participated in a lot of trials just from a sense of
adventure -- yeah I know, it sounds ridiculous now, but that was how I
approached it. "Woo-hoo, I'm going to do clinical trials to help
further M.S. research! How cool!" And you know, much of the time it
actually was. I did trials for Cytoxan way back in 1993 or '94, while I
was still RR and insured, and I know that these days Cytoxan is offered
as an option to many people with M.S., so there's at least one trial I
can look back on and believe my participation actually *did* increase
knowledge and offer more choices to others, and that's personally
satisfying. :->

After I had to disability retire, and depend on Medicare for coverage
help, I began participating in trials specifically in order to get
access to meds and tests that I'd otherwise not have been able to
afford. I did Avonex and Rebif trials, I did an imaging trial hoping to
correlate MRI and MRS images with disease progression, which enabled me
to get D.M. drugs and more recent brain MRIs than my original, which
was performed in 1990. If not for the imaging trial, I'd be stuck with
the "ancient history" film, because I simply cannot afford to self-pay
for MRIs.

Clinical trials and free samples of drugs provided by my neuro were
supplements to what I got from Medicare and what I could afford to get
on my own, for many years. If I hear about clinical trials for SPMS, I
am *so* there, dude -- I just don't hear about them, since they're very
few and very far between.

If you're interested and your neuro believes yo'd be a good candidate,
heck you fit the criteria -- you *have* had a relapse within the last
12 months. In your case, I would probably go for it, but....of course,
I'm *not* you, and don't know your specific situation, so understand
I'm not saying *you* should do it, just that I probably would if it was
close by and I was eligible.
Post by Jane
OK, so now I'm at the point where I'm going to talk to my neuro about
whether I should participate in this RRMS study, since she diagnosed me
as SPMS. And of course I need more info about the negative effects.
Best of good fortune to you! :->
RD
white lynx
2006-10-01 19:48:10 UTC
Permalink
<snip>

that clinical trial I was involved with was for secondary progressive
who could walk at least 20 yards with or without aid (cane, crutches,
walker)

in that trial they were looking for people who scored between 5.0 and
6.5 on the EDSS (Kurtzke expanded disability status scale)

that was the only trial I saw either before or since then that was aimed
that secondary progressive. They certainly are few and far between

For those newer to the group I am going to repost the EDSS system in a
separate post

At the time of the trial I was in they were testing for Rebif which at
that time was looking promising for a relapse remitting. There were no
options for secondary progressive. Now we have novantrone which I was
offered but declined because it has a lifetime limit and I wanted to
save that option in case this disease starts to affect my ability to
swallow order to talk

I must agree with my neurologist who said most people seem so frightened
by the idea of using a wheelchair or not been able to walk without
mobility aids. He said that that was nothing compared to be losing the
ability to use your hands. I definitely agree with that, although some
people may find that hard to believe. I saw a wheelchair that something
icon to wait to get to make my life easier rather than something to be
frightened of.

I am at peace with the idea that I am currently quadriplegic although it
took a few months to start using that phrase because I don't think of
myself as being quadriplegic. When I step back and look at it
rationally I definitely am. I no longer can open the envelopes,sign my
name or hold onto a piece of paper let alone turn pages in a newspaper
or book. I used to be able to hold on to a small sandwich but even that
is difficult now. No popcorn in movies because I can't pick it up to
eat. As I have said before, you adapt and enjoy what you can do rather
than get mad about what you used to be able to do.

I consider myself blessed that I do not experience any pain other than a
little discomfort from tight muscles which can easily be handled by
medication. Three or four times a year I experience optic neuritis
(which I never used to) but it does not really affect my vision and all
I need to take us a couple aspirins a couple times a day. I can
honestly tell my friends and family that I feel pretty good except that
my body doesn't work.

I feel blessed to live in British Columbia, Canada. The long-term care
facility that I live in helps me with everything I need and leaves me
enough strength to frequently go out downtown or along the sea wall on
my own. The cost is dependent on your income. The rest is subsidized.

What I have trouble understanding is why a large nation like the United
States doesn't have Medicare for everyone. Right now our provinces are
discussing a national drug strategy that would result in everyone
getting the same coverage for pharmaceutical drugs no matter what part
of the country they live in. one of the big things being discussed is a
cost of catastrophic drugs. The ideal would be to provide everybody
coverage regardless of income. They are still discussing how it would
be paid for but the idea is everyone should have access to the same
drugs regardless of income.

For now I will let the United States solve its own problems (there is no
doubt they could do it if they wanted to). I'll just be happy for what
I've got.

Larry
rather than building character, adversity is more likely to reveal it
written with voice recognition software and a magic wand
If I hear about clinical trials for SPMS, I
Post by rose
am *so* there, dude -- I just don't hear about them, since they're very
few and very far between.
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