Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

NCT ID: NCT00097331

Last Updated: 2015-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SB683699

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Fraiture En Condroz, , Belgium

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Polanki, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Málaga, , Spain

Site Status

Countries

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Belgium Germany Poland Russia Spain

Other Identifiers

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683699/003

Identifier Type: -

Identifier Source: org_study_id

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