Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00097331

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	Drug: SB683699	Phase II

MedlinePlus related topics: MRI Scans Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

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

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

Show 48 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	683699/003
Study First Received:	November 22, 2004
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00097331
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

relapsing
remitting
multiple sclerosis
Relapsing-Remitting MS (RRMS)

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009