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

Phase 3

• Conditions: Migraine Disorders; Migraine Headache; Migraine; Acute Migraine
• Interventions: Drug: Topical, intra-oral ketoprofen gel; Other: Placebo gel

• Registration Number: NCT01228552
• Lead Sponsor: Behar, Caren, M.D.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Last Update Submitted: 2011-06-04
• Last Update Posted: 2011-06-08
• Study Start: 2011-12
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical, intra-oral ketoprofen gel	Topical, intra-oral ketoprofen gel	-
Placebo gel	Placebo gel	-

Primary Outcome Measures

Name	Time	Method
Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment	Within 240 minutes post-treatment

Secondary Outcome Measures

Name	Time	Method
Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals	Within 240 minutes post-treatment
Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals	Within 240 minutes post-treatment
Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment	Within 240 minutes post-treatment
Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment	Within 240 minutes post-treatment
Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment	Within 240 minutes post-treatment
Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment	Within 240 minutes post-treatment
Need for Rescue Medication between the time of dosing to 240 minutes	Within 240 minutes post-treatment

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States