Last updated: 11/04/2018 04:03:57

Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis

GSK study ID
683699/003
See study documents
Clinicaltrials.gov ID
NCT00097331
See results summary
EudraCT ID
2004-000374-31
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: SB683699
  • Drug: Placebo
    • 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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Santa Rosa, California, United States, 95403-2192
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20132
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fraiture en Condroz, Belgium, 4557
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Russia, 197022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chieti, Abruzzo, Italy, 66013
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 53 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    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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