Use Of SB-705498 In The Acute Treatment Of Migraine - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

October 9, 2008

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

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).

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00269022 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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.

Original Secondary Outcome Measures ^†

Pain free at 30mins, 1,3,4,5&6hrs ; headache relief & 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.

Descriptive Information

Brief Title ^†

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.

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Crossover Assignment, Efficacy Study

Condition ^†

Migraine, Acute

Intervention ^†

Drug: SB-705498

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Australia, Canada, Netherlands, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269022

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.