A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis
- Conditions
- ervous System Diseases: Multiple sclerosis (MS)Nervous System DiseasesMultiple sclerosis (MS)
- Registration Number
- ISRCTN31557558
- Lead Sponsor
- Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing remitting disease course.
2. Aged 18 to 55.
3. 2 relapses in the past 2 years (this is part of the ABN guidelines to use GA and Interferon).
4. EDSS 0 - 5.5 (able to walk at least 100m without aid).
5. Disease duration less than 5 years from onset (if used later in the disease may not prevent progression).
6. At least 3 of the following: patients with three or more attacks in the first two years of disease; motor involvement in early attacks (weakness/ataxia); incomplete recovery from early attacks (EDSS >1.5); 10 or more T2 weighted MRI brain lesions (these 4 items are markers of increased risk of early disability).
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method