COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097331
Recruitment Status : Completed
First Posted : November 23, 2004
Last Update Posted : April 13, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: SB683699 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of new gadolinium-enhancing lesions on monthly MRI scans

Secondary Outcome Measures :
  1. Number of other lesion types on MRI
  2. Number of relapses during treatment
  3. Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)
  4. Circulating lymphocyte and neutrophil counts
  5. Health Outcomes: MSIS-29, Employment status

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097331

Layout table for location information
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Fraiture en Condroz, Belgium, 4557
GSK Investigational Site
Hamburg, Germany, 20099
GSK Investigational Site
Hamburg, Germany, 22087
GSK Investigational Site
Polanki 117, Poland, 80-308
GSK Investigational Site
Poznan, Poland, 60-479
GSK Investigational Site
Warszawa, Poland, 02-957
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
Malaga, Spain, 29010
Sponsors and Collaborators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline Identifier: NCT00097331    
Other Study ID Numbers: 683699/003
First Posted: November 23, 2004    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
multiple sclerosis
Relapsing-Remitting MS (RRMS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases