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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Ketorolac tromethamine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80802
      • Volker Pfaffenrath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Egalet Ltd
• Investigators: Study Chair: Roger Whiting, Ph D, American Regent, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: June 5, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (Estimate): June 7, 2007

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Migraine; Ketorolac
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: ROX-2007-01