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

Study Overview
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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.

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

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Ketorolac tromethamine
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intranasal Placebo | Drug: Placebo<br>* Intranasal (IN) placebo<br>|
| Experimental: Ketorolac tromethamine<br>Intranasal ketorolac tromethamine | Drug: Ketorolac tromethamine<br>* 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 2 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 0.5 hours post-dosing | 
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 1 hour post-dosing | 
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 1.5 hours post-dosing | 
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 3 hours post-dosing | 
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 4 hours post-dosing | 
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 24 hours post-dosing | 
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 48 hours post-dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Ketorolac