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Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 22, 2004
Last updated: April 10, 2015
Last verified: April 2015
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 Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Drug: SB683699 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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

Enrollment: 261
Study Start Date: September 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00097331

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
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00097331     History of Changes
Other Study ID Numbers: 683699/003
Study First Received: November 22, 2004
Last Updated: April 10, 2015

Keywords provided by GlaxoSmithKline:
multiple sclerosis
Relapsing-Remitting MS (RRMS)

Additional relevant 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 processed this record on September 21, 2017