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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01211795
Other study ID # IND 79,629
Secondary ID
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


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
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