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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-01-31

Brief Summary

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

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Detailed Description

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

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Intranasal Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intranasal (IN) placebo

Ketorolac tromethamine

Intranasal ketorolac tromethamine

Group Type EXPERIMENTAL

Ketorolac tromethamine

Intervention Type DRUG

31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Interventions

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Ketorolac tromethamine

31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Intervention Type DRUG

Placebo

Intranasal (IN) placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No