Migraine Disorders | The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine
Migraine Disorders research study
What is the primary objective of this study?
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.
Who is eligible to participate?
Inclusion Criteria: - Established diagnosis of Migraine as per IHS with aura - Established diagnosis of Migraine as per IHS without aura - At least 2 migraines per month - At least 18 years of age Exclusion Criteria: - Pregnancy or Lactation - Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines - Chronic Daily Headache - Allergy or Sensitivity to NSAIDs - Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Topical, intra-oral ketoprofen gelKetoprofen gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Other:Placebo gelPlacebo gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Topical, intra-oral ketoprofen gel
Start Date: December 2011
Completed Date: January 2012
Phase: Phase 3
Primary Outcome: Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
Secondary Outcome: Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals
Study sponsors, principal investigator, and references
Principal Investigator: Caren Behar, MD
Lead Sponsor: Behar, Caren, M.D.