Trials you can take part in: Statins in progressive MS, and Biotin in progressive MS

biotin 2

There’s a lot to think about if you’re considering being part of a clinical trial.

Some trials are more risky than others. These two are probably less risky, but you still need to ask:

What are the potential risks?

How many people/ what percentage have these risks

What are the potential side-effects?

How many people /what percentage get these?

What can be done if I do have a side effect or risk? Is it reversible?

What are the potential benefits?

What percentage have had these benefits?

How much of these had similar condition at a similar stage to me?

How long do they last?

Is more treatment necessary?

How much does it cost?

Will you give information either to me or to my doctor about what therapy I have undergone?

How will I be monitored? Eg scans, bloodtests etc

How often will I have to return for follow up? Is there a charge?

Will they pay my travel expenses?

How will I know if it’s worked? What’s the timescale for improvement?

Is there a placebo ( dummy drug) group? If I’m in the placebo group, and the real treatment group benefit, will I have the chance to change to the treatment group?

If I have the treatment during the trial, and benefit from it, will I be able to carry on with it long term?

Biotin

I’ve posted before about biotin in MS. A medical preparation of it has been given the name MD1003, and it is now being trialled to see its effect on people with progressive MS.  If you’re interested, here are the contacts. Don’t forget to ask those questions!

Trial Location(s)
Southern General Hospital
Glasgow
Scotland
G51 4TF
Musculoskeletal Department; Freeman Hospital
Newcastle upon Tyne
NE7 7DN
Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust
Salford
M6 8HD
Barts and The London Hospital
London
E1 2AT
University College of London, Institute of Neurology
London
WC1N 3BG
Edinburgh
EH16 4SB
Trial Contact(s)
Primary Trial Contact
abdelkarim Bendarraz

Statins

statins

I’ve also posted a long time ago about statins.

My personal suspicion is that the beneficial effects are from lowering the bad fats in the blood, and that a safer and more healthy way to do this would be to adjust lifestyle factors; primarily diet, along the lines of the advice at http://www.overcomingms.org…. However, there may be some other mode of action, or radical lifestyle change may not be possible for you, in which case, you can register your interest for the trials, so that somebody will contact you when they start recruiting, which should be very soon ( summer of 2017), here:

https://www.mssociety.org.uk/forms/ms-stat2-information

Its’ been a long gap –  hope to post again much sooner this time,

all the best

Miranda

 

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Primary Progressive MS drug trial recruiting – Laquinimod

MRI

This drug trial is now recruiting for people with PPMS, in London. It’s a drug with exciting possibilities, not a ‘repurposed’ medication.

Here’s what Professor Giovannonni of Barts hospital and http://multiple-sclerosis-research.blogspot.com has to say about Laquinimod:

“As you are aware I am very impressed by the laquinimod phase 3 results. Why? Laquinimod is a drug that does not have much effect on inflammatory MS disease activity, i.e. relapses and MRI activity (Gd-enhancing and new T2 lesions). Despite its weak anti-inflammatory effects laquinimod has an impact on disability progression, that appears to be independent of relapses and it slows the rate of brain atrophy. All this points to laquinimod having neuroprotective effects downstream of inflammation. It now appears that laquinimod may be working on glial cell activity and the innate immune system; laquinimod down-regulates the mechanisms responsible for the slow-burn we see in MSers. Are the laquinimod results reliable? Almost certainly they are; why? Mainly because there has been two large phase 3 studies showing the same effect. This makes  the chances of this being a chance result highly unlikely.”

and here’s another post about it from the pharma side:

http://www.drugdevelopment-technology.com/news/newsteva-and-active-biotech-enrol-first-patient-in-laquinimod-phase-ii-trial-for-ppms-4561605

and here’s the link to the trial site from NHS choices website.

http://www.nhs.uk/Conditions/Multiple-sclerosis/Pages/clinical-trial-details.aspx?TrialId=NCT02284568&Condition=Multiple%20sclerosis&pn=1&Rec=0&CT=0

Exciting opportunity if it feels like you have nothing to lose, but ALWAYS REMEMBER TO ASK THESE QUESTIONS!

Questions to ask when considering taking part in a trial:

What are the potential risks?
How many people/ what percentage have these risks
What are the potential side-effects?
How many people /what percentage get these?
What can be done if I do have a side effect or risk? Is it reversible?
What are the potential benefits?
What percentage have had these benefits?
How much of these had similar condition at a similar stage to me?
How long do they last?
Is more treatment necessary?
How much does it cost?
Will you give information either to me or to my doctor about what therapy I have undergone?
How will I be monitored? Eg scans, bloodtests etc
How often will I have to return for follow up? Is there a charge?
Will they pay my travel expenses?
How will I know if it’s worked? What’s the timescale for improvement?
Is there a placebo ( dummy drug) group? If I’m in the placebo group, and the real treatment group benefit, will I have the chance to change to the treatment group?
If I have the treatment during the trial, and benefit from it, will I be able to carry on with it long term?

All the best!

Miranda

 

 

Biotin for progressive MS – possible new treatment

Happy spring, everyone! Hopeful news for new treatments for progressive MS recently.secondary progressive MS

First up, Biotin. A new study using this common vitamin reported reduction in disability for 21 out of 23 participants with progressive MS.

Twenty-three consecutive patients were treated with high doses of biotin ranging from 100 mg to 600 mg/day (median=300 mg/day divided in three doses) for 2 to 36 months (average of 9.2 months).  Fourteen patients suffered from Primary Progressive MS and 9 from Secondary Progressive MS. Five patient had visual problems, and 18 patients  had problems with disability related to spinal cord involvement. Assessment was of visual measures, walking distance, EDSS, TW25, muscle strength testing and videotaped clinical examination in a subset of patients; also  fatigue, swallowing difficulties, dysarthria, Uhthoff׳s phenomenon and urinary dysfunction.

21 out of 23 participants showed evidence of improved disability, 2 to 8 months after starting treatment. This was an open study – in other words both the people with MS and their doctors knew what treatment they were receiving; which can bias the results.

Possible modes of action of Biotin were suggested to be: activating the Krebs cycle in demyelinated axons to increase energy production, and assisting in synthesisng the long chain fatty acids that are needed to produce myelin.

Conclusions, of course, are the ‘more research is needed’, and  luckily, two multi-centre double-blind placebo-controlled trials are currently underway.

But to understand more how this information can be used at the current time, let’s look into:

What is Biotin?

foods-high-in-biotin

Biotin is a form of vitamin B, present in many foods and available as a supplement  under many names, including  vitamin B7, vitamin H, biotina, biotine, and coenzyme R.

Biotin works by breaking down food into sugar that the body can use for energy; it’s important for healthy skin and nails, eyes, liver, and nervous system, and sold as a supplement to aid hair and nail growth, at strengths of up 10,000 micrograms.

In this study it was used in such a high dose – 100 – 600 miligrams – ( there are 1000 micrograms in 1 milligram)  that it’s counted as a drug and called MD1003, rather than a nutritional supplement.

Biotin exists naturally in many foods; highest sources shown below:

Interestingly those gut bacteria pop up AGAIN! – Most bacteria in the gut synthesise Biotin, it’s possible that humans make use of the biotin they create, and for those on long term antibiotics or medication designed to manage epilepsy ( and often used for pain in MS), and, in people with neurological conditions such as MS the ability to synthesis biotin can be compromised, and lower levels of biotin than usual were found in the cerebrospinal fluid in one study. Another reason to keep those good bacteria happy!

Food Serving Biotin (mcg) (32, 33)
Yeast 1 packet (7 grams) 1.4-14
Bread, whole-wheat 1 slice 0.02-6
Egg, cooked 1 large 13-25
Cheese, cheddar 1 ounce 0.4-2
Liver, cooked 3 ounces* 27-35
Pork, cooked 3 ounces* 2-4
Salmon, cooked 3 ounces* 4-5
Avocado 1 whole 2-6
Raspberries 1 cup 0.2-2
Cauliflower, raw 1 cup 0.2-4
*A 3-ounce serving of meat is about the size of a deck of cards

Of course, nobody is recommending people with MS go out and take these giant doses of Biotin themselves. However, Biotin is not known to be toxic.On the trial, there were 2 deaths, but from unrelated causes – one heart failure, and one pneumonia.  Oral biotin supplementation has been well-tolerated in doses up to 200,000 mcg/day in people with hereditary disorders of biotin metabolism (1). In people without disorders of biotin metabolism, doses of up to 5,000 mcg/day for two years were not associated with adverse effects (35). However, there is one case report of life-threatening eosinophilic pleuropericardial effusion in an elderly woman who took a combination of 10,000 mcg/day of biotin and 300 mg/day of pantothenic acid for two months (36). Due to the lack of reports of adverse effects when the Dietary Reference Intakes (DRI) were established for biotin in 1998, the Institute of Medicine did not establish a tolerable upper intake level (UL)for biotin (1).

From the MS_research blog of UCL:

Gavin Giovannoni commented:

Please note that OTC (over-the-counter) biotin is not the same as the high-dose, ultrapure, MD1003 formulation. Representatives of the company, developing the drug, have informed me that most OTC vitamin preparations have very little bioactive biotin in them. This is why I would not recommend using OTC formulations unless they are tested and certified to have bioactive biotin in them.

And another interested party added this information:

Doing some Googling, the best guess of what MedDay mean by ‘bioactive biotin’ is d-biotin, one of 8 stereoisomers of Biotin, and the only one to be biologically active (https://books.google.co.uk/books?id=iX3Bm85KQVAC&pg=PA105)

It seems to me that the question is therefore whether a given OTC formulation contain d-biotin or other isomers too.

From further Googling, some of the OTC suppliers/manufacturers claim that their product is d-biotin:

http://www.privatelabelnutra.com/biotin-10000-mcg-p-832.html
http://www.swansonvitamins.com/swanson-premium-biotin-5-mg-100-caps
http://www.toxinless.com/biotin

There is a facebook group where people share information about Biotin for Progressive MS, and presumably, where they have obtained it:

https://www.facebook.com/groups/BiotinForProgressiveMS/

The study itself is a good and interesting read:

Sedel F, et al.

High doses of biotin in chronic progressive multiple sclerosis: A pilot study.
Multiple Sclerosis and Related Disorders 2015;4:159-69.Read the full text

1) http://www.ncbi.nlm.nih.gov/pubmed/10577274
Cerebrospinal fluid levels of biotin in various neurological disorders.
Acta Neurol Scand. 1999 Jun;99(6):387-92.