Use Of SB-705498 In The Acute Treatment Of Migraine

Migraine, Acute Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269022
• Other study ID #: SB-705498/008
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: May 15, 2009
• Start date: January 2006

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine, Acute

Intervention

Drug:
• SB-705498

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Randwick	New South Wales
Canada	GSK Investigational Site	Toronto	Ontario
Netherlands	GSK Investigational Site	Leiden
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Canada,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.