Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine - Full Text View

Sponsored by:	Roxro Pharma
Information provided by:	Roxro Pharma
ClinicalTrials.gov Identifier:	NCT00483717

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	Phase II

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Ketorolac Ketorolac tromethamine Tromethamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Roxro Pharma:

Primary Outcome Measures:

The proportion of treated subjects who become pain-free (IHS Grade 0) 2 hours after dosing [ Time Frame: 2 hours after dosing ]

Secondary Outcome Measures:

Proportion of subjects pain-free (IHS Grade 0 headache) at 0.5, 1, 1.5, 3, 4, 24, and 48 hours post-dosing. [ Time Frame: Up to 48 hours after dosing ]

Estimated Enrollment:	140
Study Start Date:	July 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
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;
Medical history that would preclude NSAID use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483717

Locations

Germany, Bavaria
Volker Pfaffenrath
Munich, Bavaria, Germany, 80802

Sponsors and Collaborators

Roxro Pharma

Investigators

Study Chair:

Roger Whiting, Ph D

Roxro Pharma

More Information

Study ID Numbers:	ROX-2007-01
Study First Received:	June 5, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00483717
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Roxro Pharma:

Migraine
Ketorolac

Study placed in the following topic categories:

Migraine Disorders
Ketorolac
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Ketorolac Tromethamine
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009