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Sponsored by: |
BTG International |
---|---|
Information provided by: | BTG International |
ClinicalTrials.gov Identifier: | NCT00888680 |
The study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: BGC20-1531 Drug: Lactose |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multinational, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, 3-Way Crossover Study in Migraine Patients, Treated With Two Doses of BGC20-1531 and Placebo |
Estimated Enrollment: | 100 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
BGC20-1531 200 mg: Experimental |
Drug: BGC20-1531
BGC20-1531 administered orally
|
BGC20-1531 400mg: Experimental |
Drug: BGC20-1531
BGC20-1531 administered orally
|
Lactose: Placebo Comparator |
Drug: Lactose
Placebo administered orally
|
Migraine headache is estimated to affect 10-20% of the world population and is listed by the World Health Organisation in the top 20 causes of disabling conditions, and in the top four neurological disabling conditions. The most common therapies for acute migraine are non-steroidal anti-inflammatory drugs (NSAIDs) and triptans. However, many migraine sufferers do not experience sufficient relief from these treatments or cannot tolerate their gastrointestinal, cardiovascular and other side-effects.
Prostaglandin PGE2-induced sensory nerve sensitisation, neuropeptide release and cerebral vascular dilatation is thought to underlie migraine pain, particularly via activation of the EP4 receptor subtype. BGC20-1531 is an orally available EP4 receptor antagonist which inhibits prostaglandin-induced vasodilation of cranial blood vessels via a selective blockade of EP4 receptors reducing inflammation and migraine pain. As EP4 receptors are discretely localised, the overall safety profile of EP4 receptor antagonists may be improved compared to triptans and NSAIDs.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emma Thomas, PhD | +44(0)2075750000 ext 1616 | emma.thomas@btgplc.com |
Contact: Carol Routledge, PhD | +44(0)2075750000 ext 1594 | carol.routledge@btgplc.com |
Denmark | |
Danish Headache Center | |
Glostrup, Denmark | |
Norway | |
Head and Neck Research Group | |
Oslo, Norway | |
Norwegian National Headache Centre | |
Trondheim, Norway | |
United Kingdom | |
The City of London Migraine Clinic | |
London, United Kingdom |
Principal Investigator: | Messoud Ashina, MD | Danish Headache Center |
Responsible Party: | BTG International Ltd ( Emma Thomas, Clinical Development Executive ) |
Study ID Numbers: | BGC20-1531-06 |
Study First Received: | April 27, 2009 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00888680 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency |
Migraine Headaches Migraine headaches Head pain |
Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Pain Brain Diseases Headache Disorders |
Migraine Disorders Nervous System Diseases Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |