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Clinical Trials/NCT00097331
NCT00097331
Completed
Phase 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

GlaxoSmithKline1 site in 1 country261 target enrollmentSeptember 2004
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ConditionsMultiple Sclerosis, Relapsing-Remitting
DrugsSB683699

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Multiple Sclerosis, Relapsing-Remitting
Sponsor
GlaxoSmithKline
Enrollment
261
Locations
1
Primary Endpoint
Number of new gadolinium-enhancing lesions on monthly MRI scans
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
July 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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

Study Sites (1)

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