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Completed

NCT Number: NCT00097331

Three Months Treatment With SB683699 In Patients 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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB683699

Drug

Primary outcomes

  1. Number of new gadolinium-enhancing lesions on monthly MRI scans

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Nov 23, 2004
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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