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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?

Migraine Disorders

Migraine Headache

Migraine

Acute Migraine

Study Interventions

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.

Study Arms

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

Placebo gel

Study Status

Unknown status

Start Date: December 2011

Completed Date: January 2012

Phase: Phase 3

Type: Interventional

Design:

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.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01228552

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