The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine

Behar, Caren, M.D.

Status and phase: Unknown; Phase 3

Conditions: Acute Migraine; Migraine Disorders; Migraine Headache; Migraine

Treatments: Other: Placebo gel; Drug: Topical, intra-oral ketoprofen gel

Study type: Interventional

Identifiers

NCT01228552

79,629

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Topical, intra-oral ketoprofen gel

Active Comparator group

Treatment:

Drug: Topical, intra-oral ketoprofen gel

Placebo gel

Placebo Comparator group

Treatment:

Other: Placebo gel