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Completed

NCT Number: NCT00483717

Efficacy and Safety of Intranasal Ketorolac 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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Volker Pfaffenrath

Munich, Bavaria, 80802, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Placebo

Drug

Intranasal (IN) placebo

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Egalet Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 7, 2007
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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