NCT00097331CompletedPhase 2
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 261
- Locations
- 12
- Primary Endpoint
- Number of new gadolinium-enhancing lesions on monthly MRI scans
Study Overview
Brief Summary
The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance imaging (MRI) scans as the main measure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of multiple sclerosis (MS).
- •Expanded Disability Status Score 0 - 6.
- •One or more relapse of MS in previous 12 months.
- •Currently not taking any medications for MS (apart from those used to treat symptoms).
Exclusion Criteria
- •Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results.
- •Subjects who cannot have MRI scans.
- •Women who are pregnant, breast feeding or planning to become pregnant during the study.
Outcomes
Primary Outcomes
Number of new gadolinium-enhancing lesions on monthly MRI scans
Secondary Outcomes
- Health Outcomes: MSIS-29, Employment status
- Number of relapses during treatment
- Circulating lymphocyte and neutrophil counts
- Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)
- Number of other lesion types on MRI
Investigators
Study Sites (12)
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