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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd
ClinicalTrials.gov Identifier:
NCT00483717
First received: June 5, 2007
Last updated: September 22, 2016
Last verified: September 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 5, 2007
Results First Received: August 31, 2012
Last Updated: September 22, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016