Last updated: 01/29/2021 18:10:06

Use Of SB-705498 In The Acute Treatment Of Migraine

GSK study ID
SB-705498/008
See study documents
Clinicaltrials.gov ID
NCT00269022
EudraCT ID
2005-004480-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A single blind, placebo controlled, multi-centre study to investigate the pharmacokinetics, safety, tolerability and pharmacodynamics of the TRPV1 antagonist SB-705498 against the pain of acute migraine.
Trial description: Despite the success of the triptan class of drugs, approximately 60% of patients who take medication at the moderate to severe pain stage of acute migraine, still have pain of mild or greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor antagonist under development for the treatment of migraine pain. Preclinical experiments have demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse established central sensitisation.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: SB-705498
    • Enrollment:
    70
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Migraine, acute
    Product
    SB705498
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to August 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    no
    • Healthy subjects suffering from moderate to severe migraine headache with or without aura.
    • Women of child bearing potential must use an effective method of contraception.
    • Headache for 15 days/month or greater in any of the three months (90 days) preceding entry into the study.
    • Use of migraine medications (e.g., ergotamine, triptan, opioid, or combination medication) on >/= 10 days per month on a regular basis for >/= 3 months.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy subjects suffering from moderate to severe migraine headache with or without aura.
    • Women of child bearing potential must use an effective method of contraception.
    • Have had at least a 1 year history of migraine and the age of onset was prior to 50 years.
    • Suffering 1 to 6 migraine attacks per month for at least the last 3 months and should have at least 48 hours free of headache between migraine attacks.
    Exclusion criteria:
    • Headache for 15 days/month or greater in any of the three months (90 days) preceding entry into the study.
    • Use of migraine medications (e.g., ergotamine, triptan, opioid, or combination medication) on >/= 10 days per month on a regular basis for >/= 3 months.
    • Use of analgesics >/=15 days per month for >/=3 months, uses an opiate (except codeine) as first line treatment for migraine.
    • Migraine symptoms do not respond to any of the triptan drugs (e.g., Imitrex, Relpax, Maxalt).
    • Have uncontrolled hypertension or a history/ presence of multiple cardiovascular risk factors such as, but not limited to family history, myocardial infarction, coronary artery disease, vasospastic angina, heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease, including transient ischemic attack, stroke or peripheral arterial disease.
    • History of alcohol, substance or drug abuse within the last year.
    • Participation in a trial with a new chemical entity within 3 months before the start of the study.
    • Participation in any other research trial within 30 days prior to the first dose of current study medication is not permitted.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    LEIDEN, Netherlands, 2333 ZA
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M1L 4S4
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Randwick, New South Wales, Australia, 2031
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-22-08

    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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    Access to clinical trial data by researchers
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