ISRCTN31557558CompletedNot Applicable
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
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)0 sites0 target enrollmentStarted: September 30, 2005Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •Not provided at time of registration
Investigators
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