Feb 10, 2009
MS Trial Alert: Researchers Recruiting People with Early MS in San Francisco Bay Area for Study of Riluzole for Neuroprotection
Summary: Emmanuelle Waubant, MD, PhD, and investigators at the University of California, San Francisco are studying the possible nerve-protecting effects of oral riluzole (Rilutek®, sanofi-aventis) in people with clinically isolated syndrome (CIS, a single, isolated neurologic event suggesting loss of nerve-insulating myelin), or early MS, when combined with Avonex® (interferon beta-1a, Biogen Idec). This study is funded by the National MS Society.
Please note: This is a study of 40 people, and the investigators are still seeking a significant number of participants. Participation requires frequent travel to the study site in San Francisco.
Rationale: A molecule called glutamate has been identified in MS brain lesions. Glutamate helps excite nerve cells. Some research suggests that too much glutamate may contribute to tissue damage in MS. This team is testing the ability of riluzole to prevent the release of glutamate and, it is hoped, protect nerve fibers from damage in MS. Riluzole is already approved by the U.S. FDA for treating ALS (Lou Gehrig’s disease).
Eligibility and Details: Participants should be between 18 and 55 years of age; have early MS or have had a CIS in the past 12 months; and have not taken disease-modifying therapies for MS.
Participants will be randomly assigned to receive either riluzole together with Avonex, or Avonex together with inactive placebo for two years. Both treatments will be provided at no cost to the participant. The primary endpoints of the study are drug safety, as well as the effect of treatment on disease activity in MRI scans. Secondary endpoints include changes in a brain chemical (n-acetyl aspartate) that is measured on MRI scans and serves as a marker of nerve fiber integrity.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email elena.kornyeyeva@ucsf.edu.
Rilutek is a registered trademark of sanofi-aventis.
Avonex is a registered trademark of Biogen Idec.