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

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Ketorolac tromethamine

• Registration Number: NCT00483717
• Lead Sponsor: Egalet Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-07
• Study Start: 2007-07
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2012-08-31
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Results First Posted: 2016-09-30
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intranasal Placebo
Ketorolac tromethamine	Ketorolac tromethamine	Intranasal ketorolac tromethamine

Primary Outcome Measures

Name	Time	Method
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.	2 hours after dosing	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

Secondary Outcome Measures

Name	Time	Method
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	48 hours post-dosing	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

Trial Locations

Locations (1)

Volker Pfaffenrath; 🇩🇪 Munich, Bavaria, Germany