NCT00242866

Use Of GW274150 In The Prophylactic Treatment Of Migraine

A Multicentre, Two-part, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic Treatment of Migraine.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the prevention of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine headache.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	GW274150	The tablets used in this study will contain either 5mg or 30mg of GW274150
OTHER	Placebo	Placebo to Match GW274150

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-10-21
• Last updated: 2016-05-09

Locations

62 sites across 9 countries: Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain