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Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00097331
First received: November 22, 2004
Last updated: April 11, 2013
Last verified: March 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Estimated Enrollment: 260
Study Start Date: September 2004
Intervention Details:
    Drug: SB683699
    Other Name: SB683699
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097331

Locations
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Fraiture en Condroz, Belgium, 4557
Germany
GSK Investigational Site
Hamburg, Germany, 22087
GSK Investigational Site
Hamburg, Germany, 20099
Poland
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
Spain
GSK Investigational Site
Malaga, Spain, 29010
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00097331     History of Changes
Other Study ID Numbers: 683699/003
Study First Received: November 22, 2004
Last Updated: April 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013