Last updated: 11/04/2018 04:03:57
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of new gadolinium-enhancing lesions at Week 8, 12 and 16
Timeframe: Week 8, 12 and 16
Secondary outcomes:
Number of persistent gadolinium-enhancing lesions on Week 8, 12 and 16
Timeframe: Week 8, 12 and 16
Number of new/enlarging T2 lesions at Week 8, 12 and 16
Timeframe: Week 8, 12 and 16
Number of new T1 hypointense lesions on Week 8, 12 and 16
Timeframe: Week 8, 12 and 16
Number of total enhancing lesions on Week 8, 12 and 16
Timeframe: Week 8, 12 and 16
Number of new active lesions on Week 8, 12 and 16
Timeframe: Week 8, 12 and 16
Number of participants who experienced relapses during the treatment period upto Week 16
Timeframe: Week 0, 4, 6, 8, 10, 12, 14, 16, 20 and 24
Expanded Disability Status Scale at Week 16 and 24
Timeframe: Week 16 and 24
Multiple Sclerosis Functional Composite (MSFC) at Week 16 and 24
Timeframe: Week 16 and 24
Circulating lymphocyte and neutrophil count up to Week 16
Timeframe: Week 8, 12 and 16 at pre-dose, 1 hour, 2 hours and 4 hours post dose
Assessment of pharmacokinetic parameter maximum observed concentration (Cmax) for SB-683699 and metabolite GW786375X upto Week 12
Timeframe: Pre-dose, 1, 2 and 3 hours post-dose at Weeks 4, 6, 8, 12.
Assessment of pharmacokinetic parameter area under the curve over the dosing interval from 0 to 12 hours[AUC (0-12)] for SB-683699 and metabolite GW786375X
Timeframe: Pre-dose, 1, 2 and 3 hours post-dose at Weeks 4, 6, 8, 12
Multiple Sclerosis Impact Scale (MSIS-29) via physical impact and psychological impact at Week 16 and Week 24
Timeframe: Week 16 and 24
Number of participants with Employment Status assessment at Week 16
Timeframe: Week 16
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to follow-up (Week 24)
Interventions:
Enrollment:
261
Primary completion date:
2006-21-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Sclerosis, Relapsing-Remitting
Product
firategrast
Collaborators
Not applicable
Study date(s)
September 2004 to July 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Diagnosis of multiple sclerosis (MS).
- Expanded Disability Status Score 0 - 6.5.
- Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results.
- Subjects who cannot have MRI scans.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Santa Rosa, California, United States, 95403-2192
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
Northbrook, Illinois, United States, 60062
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1W8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03766
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23601
Status
Study Complete
Location
GSK Investigational Site
Plainview, New York, United States, 11803
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85013
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30338
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2006-21-07
Actual study completion date
2006-21-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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