NCT00172094

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DRUG	NPS 1776 (800 mg)	NPS 1776 (800 mg) powder
DRUG	PLACEBO	Placebo in non-carbonated fruit flavored drink (150 ml)
DRUG	NPS 1776 (400 mg)	NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink

Timeline

• Start date: 2003-12-31
• Primary completion: 2004-06-30
• Completion: 2004-07-31
• First posted: 2005-09-15
• Last updated: 2021-06-03

Locations

22 sites across 1 country: United States