Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

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

Details

• Lead Sponsor: Egalet Ltd
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);

• Onset of migraine prior to age 50;

• 2-8 moderate to severe migraine headaches per month

Exclusion Criteria:

• Subjects receiving any investigational drug within 30 days before study entry;

• More than 15 headache days per month;

• Known allergy or hypersensitivity to ketorolac and/or excipients;

• Allergy to aspirin or other NSAIDs;

• Currently receiving other NSAIDs or aspirin;

• Medical history that would preclude NSAID use