Location: National study sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), based in Bethesda, MD

Purpose: To examine the safety and effectiveness of Zenapax (a laboratorymanufactured antibody) in treating MS.

Eligibility:
• Women and men aged 18 to 65 years
• Persons with relapsing-remitting or secondary progressive MS who have had more than one relapse within 18 months preceding study enrollment
• EDSS score between 2.5 and 6.5, inclusive
• Have failed standard IFN-beta therapy • Must have at least two Gd-enhancing lesions or greater in the 3 pre-treatment MRI scans (an average of at least 0.67 Gd-enhancing lesions per scan).

Procedures: Three MRI scans over initial 2 months to evaluate disease activity. During treatment, receive seven IV infusions of Zenapax––the first two will be given 2 weeks apart; the next five will be given once a month. Before each infusion, participants will have two MRI scans, one using standard procedure and one using gadolinium. Blood and urine samples will be taken at each visit. There will be skin tests. A lumbar puncture will be done at the beginning and at end of the treatment phase. Lymphocytes will be collected before, during, and after treatment.

Benefit: May lead to a new treatment for RRMS or SPMS.

For Information: Contact the NIH Patient

This entry was posted on Monday, July 11th, 2005 at 8:30 pm and is filed under All Articles, MS Study Enrollments. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.