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Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches

Migraine Headache Clinical Trial

Official title:
A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00172094
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date December 31, 2003
Completion date July 31, 2004
View Details
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