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Sponsored by: |
NPS Pharmaceuticals |
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Information provided by: | NPS Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00172094 |
The purpose of this study was to evaluate the effectiveness and safety of a single oral dose of NPS 1776 in the acute treatment of migraine pain and associated symptoms.
Condition | Intervention | Phase |
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Migraine Headache |
Drug: NPS 1776 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches |
Estimated Enrollment: | 300 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | June 2004 |
Migraine, the most common cause of recurrent severe or disabling headache, is diagnosed on the basis of a clinical history of intermittent headache with autonomic, constitutional, and neurologic disturbances.
Many antiepileptic drugs (AEDs) have demonstrated efficacy as acute and/or prophylaxis therapy for migraine, even though the mechanism of action of the various AEDs is poorly understood.
NPS 1776, isovaleramide, is a neutral aliphatic amide. The mechanism by which NPS 1776 exerts its therapeutic actions in nonclinical animal models of disease is unclear. The same is true for many antiepileptics on the market today. NPS 1776 does not appear to bind directly to various CNS receptor centers, although it shows a broad range of anticonvulsant activity in multiple animal models of seizures. This broad profile of anticonvulsant activity is similar to that of valproic acid (VPA), and may also predict NPS 1776 efficacy in the treatment of migraine.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CL1776-005 |
Study First Received: | September 9, 2005 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00172094 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Migraine |
Signs and Symptoms Migraine Disorders Headache Central Nervous System Diseases Neurologic Manifestations |
Headache Disorders, Primary Pain Brain Diseases Headache Disorders |
Signs and Symptoms Migraine Disorders Nervous System Diseases Headache Central Nervous System Diseases |
Neurologic Manifestations Headache Disorders, Primary Pain Brain Diseases Headache Disorders |