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

Migraine Clinical Trial

Official title:

A Randomized Double Blind, Placebo Controlled Phase III Trial to Determine the Efficacy and Safety of Topical Intra-oral Ketoprofen for the Treatment of Acute Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01228552
• Other study ID #: 79,629
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 25, 2010
• Last updated: June 4, 2011
• Start date: December 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2010
• Source: Behar, Caren, M.D.
• Contact: Caren Behar, MD
• Phone: 914-584-2413
• Email: ardavsa[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Migraine
• Migraine
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• Topical, intra-oral ketoprofen gel
Ketoprofen 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 gel
Placebo 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.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Behar, Caren, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment		Within 240 minutes post-treatment	No
Secondary	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	No
Secondary	Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals		Within 240 minutes post-treatment	No
Secondary	Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment		Within 240 minutes post-treatment	No
Secondary	Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment		Within 240 minutes post-treatment	No
Secondary	Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment		Within 240 minutes post-treatment	No
Secondary	Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment		Within 240 minutes post-treatment	No
Secondary	Need for Rescue Medication between the time of dosing to 240 minutes		Within 240 minutes post-treatment	No