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

A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine

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

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

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