Topical Intra-Oral Ketoprofen for Migraine Prevention

Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.

Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: topical intraoral ketoprofen gel; Other: Placebo Gel

Detailed Description

This is a 4 month trial. During the first month, a prospective headache diary is maintained. Migraine frequency, severity (1-10), duration, and all headache medications are recorded.

Patients are then randomized to receive active gel or placebo gel in double blind fashion.

Gel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as outlined above, is maintained throughout the trial. Patients may continue to take other migraine medications, as needed. No other new migraine therapies may be started during the trial.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • New York Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IHS Migraine with or without aura
• 18 y.o. or older
• at least 4 migraines per month

Exclusion Criteria:

• pregnancy
• other headache conditions
• chronic daily headache
• allergy or sensitivity to NSAIDs other severe illnesses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo gel	Other: Placebo Gel; An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.
Active Comparator: Topical Ketoprofen gel	Drug: topical intraoral ketoprofen gel; 20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of migraine days per month	Number of migraine days per month will be compared before gel use and at the end of 3 months of use.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in migraine severity	Average migraine severity on a scale of 1-10, will be compared prior to gel use, and at the end of 3 months	3 month total
Change in migraine duration	Average migraine duration will be compared prior to gel use, and at the end of 3 months	3 months
Change in headache medication use	Change in headache medication use will be compared prior to gel use, and at the end of 3 months	3 months

Collaborators and Investigators

• Sponsor: Behar, Caren, M.D.
• Investigators: Principal Investigator: Caren Behar, MD, New York Medical College

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 30, 2010

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 4, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Treatment; Migraine; Prevention; Trigeminal nerve; Ketoprofen
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: IND 79,629