Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097331
• Other study ID #: 683699/003
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2004
• Last updated: April 10, 2015
• Start date: September 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• SB683699

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Fraiture en Condroz
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Poland	GSK Investigational Site	Polanki 117
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Warszawa
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
Spain	GSK Investigational Site	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Germany,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of new gadolinium-enhancing lesions on monthly MRI scans
Secondary	Number of other lesion types on MRI
Secondary	Number of relapses during treatment
Secondary	Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)
Secondary	Circulating lymphocyte and neutrophil counts
Secondary	Health Outcomes: MSIS-29, Employment status