Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097331

Enrollment

261

Registered

2004-11-23

Start date

2004-09-30

Completion date

2006-07-31

Last updated

2015-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

multiple sclerosis, relapsing, remitting, Relapsing-Remitting MS (RRMS)

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.

Interventions

DRUGSB683699

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of new gadolinium-enhancing lesions on monthly MRI scans	—

Secondary

Measure	Time frame
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	—

Countries

Belgium, Germany, Poland, Russia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026