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MS Trial Alert: Investigators Recruiting for Study of High-Dose Biotin (MD1003) in Progressive MS

May 17, 2017

Summary: Investigators worldwide are conducting a clinical trial testing high-dose biotin (MD1003, MedDay Pharmaceuticals SA) versus inactive placebo in 600 people with secondary or primary progressive MS. Participants can remain on existing disease-modifying treatments (such as ocrelizumab), if treatment has been stable for at least 90 days prior to enrollment. The study is sponsored by MedDay.
 
Rationale: Biotin is considered a form of vitamin B, and is a component of enzymes in the body that generate energy for cells. Biotin, also known as vitamin H, is usually obtained from food in tiny concentrations. High dose, pharmaceutical grade biotin (concentration >10,000 times the usual daily dose, or MD1003) was tested in a clinical trial in France involving 154 people with primary-progressive MS or secondary-progressive MS. They were given high-dose biotin (MD1003) or inactive placebo for 48 weeks. The results suggested that 12.6% of those given MD1003 showed improvement in disability (using either the EDSS scale that measures disability progression, or improvement in a timed walk), versus none of those on placebo, and there were no serious safety issues reported. (MS Journal 2016 Nov;22(13):1719-173)
 
Eligibility and Details: Participants are aged 18-65 years old with a diagnosis of primary or secondary progressive MS. Participants can remain on existing disease-modifying treatments, if treatment has been stable for at least 90 days prior to enrollment. Further criteria are available from the contact below.
 
Participants are being randomly assigned to receive a capsule of MD1003 100 mg or a placebo capsule three times daily for 15 months. When all study participants have completed 15 months of double-blind therapy, all patient may enter an open label extension where all participants will receive MD1003 100 mg three times daily for 12 months.
 
The primary outcome being measured is the proportion of participants who improve on either the EDSS scale that measures disability or a test that measures mobility. Other outcomes being measured include cognitive function, quality of life, and activity on MRI scans.
 
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit www.spi2study.com or call Dr. Robert Lasser at 617-378-8701.
 
Sites are or will soon be enrolling in the following cities:
 
Phoenix, Arizona
Scottsdale, Arizona
Berkeley, California
Los Angeles, California
Newport Beach, California
Sacramento, California
San Francisco, California
Aurora, Colorado
North Haven, Connecticut
Miami, Florida
Sunrise, Florida
Chicago, Illinois
Kansas City, Kansas
Baltimore, Maryland
Boston, Massachusetts
Detroit, Michigan
Saint Louis, Missouri
Teaneck, New Jersey
Albuquerque, New Mexico
Buffalo, New York
New York, New York
Rochester, New York
Stony Brook, New York
Raleigh, North Carolina
Cleveland, Ohio
Portland, Oregon
Philadelphia, Pennsylvania
Knoxville, Tennessee
Nashville, Tennessee
Dallas, Texas
Round Rock, Texas
Salt Lake City, Utah
Charlottesville, Virginia
Vienna, Virginia
Seattle, Washington
 
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
 
Without participants in research studies, MS research would come to a standstill. Read more here.  

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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