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

• Status: Unknown status
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ariston Pharmaceuticals, Inc.

Criteria

Primary Inclusion Criteria:

1. Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).

2. Has had migraines for at least 6 months prior to study enrollment period.

3. Migraines began before age 50.

4. Has 2 to 10 attacks per month and greater than or equal to 3 migraine days per month in the last 3 months prior to study enrollment.

5. Has 2 to 10 attacks in 30 days during the Baseline Period.

Additional inclusion criteria in protocol

Primary Exclusion Criteria:

1. Has headache equal to or greater than 18 days per month.

2. Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.

3. Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine [DHE]) greater than 15 days per month.

4. Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.

5. Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.

Additional exclusion criteria in protocol