Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

April 10, 2015 updated by: GlaxoSmithKline

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Fraiture en Condroz, Belgium, 4557
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 22087
        • GSK Investigational Site
      • Hamburg, Germany, 20099
        • GSK Investigational Site
  • Poland
      • Polanki 117, Poland, 80-308
        • GSK Investigational Site
      • Poznan, Poland, 60-479
        • GSK Investigational Site
      • Warszawa, Poland, 02-957
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117049
        • GSK Investigational Site
      • Moscow, Russian Federation, 125367
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • GSK Investigational Site
  • Spain
      • Malaga, Spain, 29010
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of new gadolinium-enhancing lesions on monthly MRI scans

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

November 22, 2004

First Submitted That Met QC Criteria

November 22, 2004

First Posted (Estimate)

November 23, 2004

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 683699/003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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