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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483717
First Posted: June 7, 2007
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Egalet Ltd
  Purpose
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Condition Intervention Phase
Migraine Drug: Ketorolac tromethamine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Egalet Ltd:

Primary Outcome Measures:
  • The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. [ Time Frame: 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:
  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 0.5 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

  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 1 hour 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

  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 1.5 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

  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 3 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

  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 4 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

  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 24 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

  • The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point [ Time Frame: 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


Enrollment: 173
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483717


Locations
Germany
Volker Pfaffenrath
Munich, Bavaria, Germany, 80802
Sponsors and Collaborators
Egalet Ltd
Investigators
Study Chair: Roger Whiting, Ph D Luitpold Pharmaceuticals
  More Information

Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT00483717     History of Changes
Other Study ID Numbers: ROX-2007-01
First Submitted: June 5, 2007
First Posted: June 7, 2007
Results First Submitted: August 31, 2012
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016
Last Verified: September 2016

Keywords provided by Egalet Ltd:
Migraine
Ketorolac

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action