Drug trial for PPMS folks .......

[Lulu54]

PPMS Trial- they are recruiting patients and will pay travel expenses ..........  

http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=4502

Jan 26, 2011

Summary: Researchers at the National Institutes of Health in Bethesda, Maryland are looking to recruit 80 people with Primary-Progressive Multiple Sclerosis to evaluate the safety and effectiveness of Idebenone, an oral experimental drug. The study is funded by the National Institute of Neurological Disorders and Stroke.

Rationale: Primary-progressive is a type of MS that is described by slowly worsening neurologic function from the beginning, with no distinct pattern of relapses (temporary worsening of symptoms) or remissions (improvement of symptoms). The speed at which symptoms get worse may vary over time. People may have some periods where symptoms stay the same and may have temporary minor improvements. About 10% of people who have MS will have primary-progressive MS. There are no treatments approved to treat this type of MS.

Idebenone is a man-made drug that is similar to a naturally occurring antioxidant called coenzyme Q10, a common dietary supplement. This supplement is thought to be important in the way cells in the body work. Studies are currently ongoing to find out the safety of Idebenone and drugs like it in several diseases. In MS, researchers are trying to find out whether the drug can protect against damage to brain and spinal cord cells that contributes to the worsening disability in primary-progressive MS.

Eligibility & Details: You may be eligible to participate if you are between 18 and 65 years of age and have been diagnosed with primary-progressive MS.

You may not be able to participate if you have other types of MS, or other types of brain or spinal cord disease. If you cannot walk for 25 feet without assistance, you may not be able to participate in this study. Women who are pregnant, are breast-feeding, or are planning to become pregnant during the course of the study are not eligible.

This two-part study will last three years, with about 6 outpatient visits to the NIH Clinical Center in Bethesda, Maryland each year. Part 1 is one year long. Study tests will be done and no study drug will be given in this part of the study. In Part 2, participants will receive either Idebenone (study drug) or inactive placebo (“sugar pill”) for two years. Study tests during Part 2 will be done to see how the study drug or placebo is working.

There is no cost to take part in this study. Reimbursement for travel, lodging, and food will be offered. People in the study will not receive payment.

The primary outcome measure is to determine whether Idebenone can decrease brain atrophy – loss of brain tissue volume – significantly more than placebo.

[Lulu54]

yes, I'll repeat it again from my earlier post ....

talk to your doctor about adding this before just going to the vitamin/supplement aisle and buying the first thing you see.

[AMO]

*********** anyone on bloodthinner trying to supplement with CoQ10... PLEASE get adice from your docotr **************
...it must be wacthed VERY closely !!!


ok, I have been 'blessedd' not only with ms , but some form of Cerebellar Ataxia. IMy movement disorder neuro had me try Coq10 sometime ago,  Iii can not rememeber the doses but it   was higher than the label recommended. While I had no harmful effects, I did not see any benefitss, either  in my Ataxia or ms.
take care, amo

[patientx]

I think the safety profile for Idebenone may have already been established.  I think part of the justification for trying it with MS is that previous trials saw some benefit in Friedreich's ataxia.  There's actually a link to the study under the MS study:

http://www.clinicaltrials.gov/ct2/show/NCT00950248?term=multiple+sclerosis+idebenone&rank=1

http://www.ncbi.nlm.nih.gov/pubmed/12368988?dopt=Abstract

[twopack]

Interesting topic.  I'm always listening up when CoQ10 is mentioned.  It's one of the supplements I've found over the years that had real benefit for me (but not for MS specifically).  My mature age dictates using the more bio-available Ubiquinol.

CoQ10 is not only good for general heart health, it is essential for proper heart function and should be supplemented whenever a person is taking statin drugs (they deplete CoQ10).  Unfortunately, most docs don't think of using 'dietary supplements' as quickly as they do their prescription pad.

I don't know anything about Idebenone.  I do know that it is possible to make a very small change in one segment of a molecular structure and cause a huge difference in what it is capable of doing.  That's a wonderful thing....sometimes.  It can also be a harmful thing if we civilians decide to tinker on our own.  I think you are wise to limit your intake patientx.

It sounds like approved research on this is still in the early stage, with concentration still on establishing safety.  Sometimes only a small number of participants are needed to establish if unwanted or harmful effects are possible/probable.  Maybe they will be looking for a larger test population in the future Red.  This is NIH and would be funded with fluid federal dollars, so has contributors countrywide (especially when April 15th rolls 'round).  I know it's hard to think of wonder treatments from simple sources but please try not to let your spunky slip into doubt quite so quickly :)


I'm just glad to hear there is SOMETHING going on in the research arena to treat PPMS.  It is certainly way past time to infuse some new hope into that end of the MS spectrum.  I'm glad what they're testing is a varient of what I use.  If it was the same thing, I'd need to be stocking up before the price tag of my simple supplement blasted through the roof.

Keeping my fingers crossed (until they spasm).
Thanks for the info Lu and ptX
Mary

[patientx]

Actually, you can purchase Idebenone from online supplement suppliers.  I saw this study posted a few months ago, and decided to start taking Idebenone.  The cheapest I found is from A1 supplements.  Of course, it is pretty pricey, so I 'm not taking as much as what the trial will use.

As Lulu pointed out, Idebenone is a synthetic similar to CoQ10.  But, I did some reading about the two, and seem to remember that Idebenone was a more potent antioxidant, and that under certain conditions the CoQ10 could actually become pro-oxidant.  But it's been a while since I did that searching, so I can't remember all the details.

[doublevision1]

Very encouraging to see new studies recruiting for PPMS treatments.  Thanks for posting this, Lu.

[RedFlame]

The other thing is that they are only recruiting 66 patients, so the likliehood of participating is slim.  You can purchase the dietary supplement/vitamin 'CO-Q10 Ubiquinone' for $25.00 at Walmart.


Doesn't sound promising to me.  Probably no funding.

[Lulu54]

A key thing to point out in this study is they are looking at a variation of CO-Q10, a dietary supplement that is commonly recommeded, especialy for heart patients.  If you can't do this study you might at least talk to tyour doctor about adding co-Q10 to your regimen.  We know it won't hurt............

Lulu

[RedFlame]

Hi Lu,

I read through this and am interested.  I am thinking about taking it into my next appointment with my neuro and telling her to ___ or get off the pot because doing nothing is no longer acceptable to me.  But, I will say all of that in a respecful way.  We need to try something or it is going to be too late.  

Guess I am feeling 'spunky'.:-)

The thing is I'm not sure I would qualify with my mobility.  I can walk 25 feet---very slowly and cautiously but that's about it.  I don't have a power chair yet so navigating the airport would have to be planned extensively.  

Then, I do have other neuro things going on so I probably couldn't do it.

Anyway, this got me thinking about demanding that we try some things rather than just sitting by.

Thanks for posting this

Red

[Lulu54]

bump for Alex and others who might be interested..............