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-freeTime 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
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