Clinical trial NCT00269022: Use Of SB-705498 In The Acute Treatment Of Migraine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine, Acute
Keywords: SB-705498 acute migraine single dose TRPV1 combination inpatient outpatient study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of subjects who are pain free at 2 hrs post-dose (e.g., have moderate to severe pain at baseline and no pain at 2 hrs post-dose).
Secondary outcomes:
measure: Pain free at 30mins, 1,3,4,5&6hrs Headache relief and absence/presence of associated symptoms at 30 mins, 1,2,3,4,5&6hrs Additional migraine medication Safety tests ( e.g., continuous ECG, laboratory tests) Heat pain thresholds.
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Leiden
country: Netherlands
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: