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.
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.
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:
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Los Angeles, California
Newport Beach, California
San Francisco, California
North Haven, Connecticut
Kansas City, Kansas
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
Round Rock, Texas
Salt Lake City, Utah
Without participants in research studies, MS research would come to a standstill. Read more here.