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.
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.
To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Joan Ohayon
or Rosalind Ebinger
at 301-496-0064 (or TTY: 1-866-411-1010).
Please refer to study number 09-N-0197 (www.ClinicalTrials.gov
a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).