Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

GlaxoSmithKline261 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

261

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

SB683699DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis of multiple sclerosis (MS). * Expanded Disability Status Score 0 - 6.5. * 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.

Locations (11)

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Fraiture En Condroz, Belgium

GSK Investigational Site

Hamburg, Free and Hanseatic City of Hamburg, Germany

Outcomes

Primary Outcomes

Number of new gadolinium-enhancing lesions on monthly MRI scans

Secondary Outcomes

Number of other lesion types on MRI

Number of relapses during treatment

Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)

Circulating lymphocyte and neutrophil counts

Health Outcomes: MSIS-29, Employment status

Data from ClinicalTrials.gov

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