Use Of SB-705498 In The Acute Treatment Of Migraine

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.

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Key information

Conditions

Migraine, Acute Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Randwick, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-705498

Drug

Primary outcomes

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

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start: 2006
First posted: Dec 23, 2005
Registry last updated: May 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed