Topical Intra-Oral Ketoprofen for Migraine Prevention
This study has been completed.
Sponsor:
Behar, Caren, M.D.
Information provided by:
Behar, Caren, M.D.
ClinicalTrials.gov Identifier:
NCT01211795
First received: September 27, 2010
Last updated: June 4, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: topical intraoral ketoprofen gel Other: Placebo Gel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention. |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hemiplegic migraine
Drug Information available for:
Ketoprofen
U.S. FDA Resources
Further study details as provided by Behar, Caren, M.D.:
Primary Outcome Measures:
- Change in number of migraine days per month [ Time Frame: 3 months ] [ Designated as safety issue: No ]Number of migraine days per month will be compared before gel use and at the end of 3 months of use.
Secondary Outcome Measures:
- Change in migraine severity [ Time Frame: 3 month total ] [ Designated as safety issue: No ]Average migraine severity on a scale of 1-10, will be compared prior to gel use, and at the end of 3 months
- Change in migraine duration [ Time Frame: 3 months ] [ Designated as safety issue: No ]Average migraine duration will be compared prior to gel use, and at the end of 3 months
- Change in headache medication use [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in headache medication use will be compared prior to gel use, and at the end of 3 months
| Enrollment: | 67 |
| Study Start Date: | October 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211795
Locations
| United States, New York | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
Sponsors and Collaborators
Behar, Caren, M.D.
Investigators
| Principal Investigator: | Caren Behar, MD | New York Medical College |
More Information
No publications provided
| Responsible Party: | Caren Behar MD FACP, NYMC |
| ClinicalTrials.gov Identifier: | NCT01211795 History of Changes |
| Other Study ID Numbers: | IND 79,629 |
| Study First Received: | September 27, 2010 |
| Last Updated: | June 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Behar, Caren, M.D.:
|
Migraine Prevention Treatment Ketoprofen Trigeminal nerve |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Ketoprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013