Topical Intra-Oral Ketoprofen for Migraine Prevention

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211795
• Other study ID #: IND 79,629
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2010
• Last updated: June 4, 2011
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Behar, Caren, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

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.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Behar, Caren, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in migraine duration	Average migraine duration will be compared prior to gel use, and at the end of 3 months	3 months	No
Secondary	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	No