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Topical Intra-Oral Ketoprofen for Migraine Prevention

NCT01211795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Behar, Caren, M.D.

    lead INDIV

Principal Investigators

  • Caren Behar, MD · New York Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211795 on ClinicalTrials.gov