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

Information source: Luitpold Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: Ketorolac tromethamine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Luitpold Pharmaceuticals

Official(s) and/or principal investigator(s):
Roger Whiting, Ph D, Study Chair, Affiliation: Luitpold Pharmaceuticals

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The proportion of treated subjects who became pain-free

Secondary outcome:

The proportion of treated subjects who became pain-free

Time to pain free (IHS grade 0 headache) following dosing (using wristwatch)

Proportion of subjects with pain free relief (IHS grade 1 or 0 headache)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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;

- Medical history that would preclude NSAID use

Locations and Contacts

Volker Pfaffenrath, Munich, Bavaria 80802, Germany
Additional Information

Starting date: July 2007
Last updated: June 1, 2011

Page last updated: August 23, 2015

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