Multiple Sclerosis, Relapsing-RemittingPhase 2NCT00097331
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
A Phase 2 study testing SB683699 in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 11 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- SB683699
- How many people
- 261 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Sep 2004to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Poland3 sites
GSK Investigational Site
Polanki, 80-308
GSK Investigational Site
Poznan, 60-479
GSK Investigational Site
Warsaw, 02-957
Russia3 sites
GSK Investigational Site
Moscow, 117049
GSK Investigational Site
Moscow, 125367
GSK Investigational Site
Saint Petersburg, 197022
Belgium2 sites
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Fraiture En Condroz, 4557
Germany2 sites
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20099
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22087
About this study
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
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- SB683699
- Keywords
- multiple sclerosis, relapsing, remitting, Relapsing-Remitting MS (RRMS)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB683699Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new gadolinium-enhancing lesions on monthly MRI scans
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097331
- Sponsor's protocol ID
- 683699/003
- Status last verified
- Apr 2015
- First submitted
- 22 Nov 2004
- Last updated
- 13 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00097331
- Acronym / sponsor ID
- 683699/003
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- multiple sclerosis, relapsing, remitting, Relapsing-Remitting MS (RRMS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 23 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB683699 | Drug | – |
Primary outcome
Number of new gadolinium-enhancing lesions on monthly MRI scans
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB683699 in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, Russia, Belgium, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new gadolinium-enhancing lesions on monthly MRI scans. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.