NCT00285402

Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine

Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Ariston Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this migraine prevention study is to evaluate the efficacy and safety of AST-726 in moderate to severe migraine patients at one of two doses compared to placebo and compared to a baseline period as measured by a reduction in the number of migraine days.

Detailed description

Migraine patients may experience repeated migraine attacks, lasting from four hours to three days or more. Each attack is characterized by severe pain, typically on one side of the head and often involves a number of other symptoms, including pain with a pulsating or throbbing quality, nausea or vomiting, sensitivity to light and sound, visual disturbances or aura. Currently the management of migraine may be either acute treatment or prophylaxis. Acute migraine treatment aims at aborting or reversing already present migraine symptoms with acute administration of medicine such as with triptans, whereas migraine prophylaxis aims to reduce the frequency and severity of migraine attacks over time through chronic medication. The overall protocol design and outcome measurements of this study follow the guidelines and durations recommended by the International Headache Society for prophylaxis studies of migraine medications. The study ARPH-CL-03 is a multicenter, randomized, double-blind, three parallel group design with moderate to severe migraine patients to assess the ability of daily administration of AST-726 at one of two doses to reduce the number of headache days in a 4 week period more than in patients that receive a placebo. AST-726 and the placebo will be self-administered by intranasal spray daily for 12 weeks. Among other efficacy and safety assessments, patients will have be asked to collect information on a daily migraine diary. Patients will be instructed on the allowed use of acute migraine medications during this study.

Conditions

• Migraine
• Migraine Headache
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
DRUG	AST-726 Low dose
DRUG	AST-726 High dose
DRUG	AST-726 Placebo

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-02-02
• Last updated: 2008-02-08

Locations

19 sites across 3 countries: Finland, Netherlands, United Kingdom