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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00242866 |
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.
Condition | Intervention | Phase |
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Migraine |
Drug: GW274150 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 430 |
Study Start Date: | October 2005 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NOS103325 |
Study First Received: | October 19, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00242866 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Migraine without aura with aura Prophylaxis Nitric Oxide iNOS |
Quality of Life Productivity Safety Efficacy Pharmacokinetics GW274150 |
Nitric Oxide Migraine Disorders Headache Quality of Life |
Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Headache Disorders |
Nervous System Diseases |