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Completed

NCT Number: NCT01211795

Topical Intra-Oral Ketoprofen 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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New York Medical College

Valhalla, New York, 10595, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical intraoral ketoprofen gel

Drug

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.

Placebo gel

Other

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.

Primary outcomes

  1. Change in number of migraine days per month

    Time frame: 3 months

    Number of migraine days per month will be compared before gel use and at the end of 3 months of use.

Secondary outcomes

  1. Change in migraine severity

    Time frame: 3 month total

    Average migraine severity on a scale of 1-10, will be compared prior to gel use, and at the end of 3 months

  2. Change in migraine duration

    Time frame: 3 months

    Average migraine duration will be compared prior to gel use, and at the end of 3 months

  3. Change in headache medication use

    Time frame: 3 months

    Change in headache medication use will be compared prior to gel use, and at the end of 3 months

Sponsors and collaborators

Lead sponsor

Behar, Caren, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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