Last updated: 01/29/2021 18:10:06
Use Of SB-705498 In The Acute Treatment Of Migraine
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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