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Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB683699
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring multiple sclerosis, relapsing, remitting, Relapsing-Remitting MS (RRMS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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

Full Information

First Posted
November 22, 2004
Last Updated
April 10, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00097331
Brief Title
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
multiple sclerosis, relapsing, remitting, Relapsing-Remitting MS (RRMS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB683699
Primary Outcome Measure Information:
Title
Number of new gadolinium-enhancing lesions on monthly MRI scans
Secondary Outcome Measure Information:
Title
Number of other lesion types on MRI
Title
Number of relapses during treatment
Title
Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)
Title
Circulating lymphocyte and neutrophil counts
Title
Health Outcomes: MSIS-29, Employment status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Fraiture en Condroz
ZIP/Postal Code
4557
Country
Belgium
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
GSK Investigational Site
City
Polanki 117
ZIP/Postal Code
80-308
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-479
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

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Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

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