Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: SB683699

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097331

683699/003

Details and patient eligibility

About

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.

Enrollment: 261 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind