CClinicalTrials.gg
Sign In
CompletedNCT00097331Updated Apr 13, 2015

Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

A Phase 2 interventional study of SB683699 in Multiple Sclerosis, Relapsing-Remitting, sponsored by GlaxoSmithKline. Completed at 11 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-13.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
261
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting

Keywords

  • multiple sclerosis
  • relapsing
  • remitting
  • Relapsing-Remitting MS (RRMS)
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 261 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
261 participants (actual)

Interventions

  • DrugSB683699
06

What researchers measure

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

07

Study locations

11 sites
  • GSK Investigational Site
    Bruxelles, 1200, Belgium
  • GSK Investigational Site
    Fraiture en Condroz, 4557, Belgium
  • GSK Investigational Site
    Hamburg, 20099, Germany
  • GSK Investigational Site
    Hamburg, 22087, Germany
  • GSK Investigational Site
    Polanki 117, 80-308, Poland
  • GSK Investigational Site
    Poznan, 60-479, Poland
  • GSK Investigational Site
    Warszawa, 02-957, Poland
  • GSK Investigational Site
    Moscow, 117049, Russian Federation
  • GSK Investigational Site
    Moscow, 125367, Russian Federation
  • GSK Investigational Site
    St. Petersburg, 197022, Russian Federation
  • GSK Investigational Site
    Malaga, 29010, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00097331
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 23, 2004
Start date
Sep 2004
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Apr 13, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Multiple Sclerosis→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion