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

Egalet

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Ketorolac tromethamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483717

ROX-2007-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 173 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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173 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intranasal Placebo

Treatment:

Drug: Placebo

Ketorolac tromethamine

Experimental group

Description:

Intranasal ketorolac tromethamine

Treatment:

Drug: Ketorolac tromethamine