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

Primary Purpose

Migraine Disorders, Migraine Headache, Migraine

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Topical, intra-oral ketoprofen gel
Placebo gel
Sponsored by
Behar, Caren, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Acute Migraine Treatment, Migraine Treatment, Migraine, Headache, Treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • New York Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Topical, intra-oral ketoprofen gel

Placebo gel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2010
Last Updated
June 4, 2011
Sponsor
Behar, Caren, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01228552
Brief Title
The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Behar, Caren, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Migraine Headache, Migraine, Acute Migraine
Keywords
Acute Migraine Treatment, Migraine Treatment, Migraine, Headache, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical, intra-oral ketoprofen gel
Arm Type
Active Comparator
Arm Title
Placebo gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Topical, intra-oral ketoprofen gel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
Time Frame
Within 240 minutes post-treatment
Secondary Outcome Measure Information:
Title
Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals
Time Frame
Within 240 minutes post-treatment
Title
Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals
Time Frame
Within 240 minutes post-treatment
Title
Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment
Time Frame
Within 240 minutes post-treatment
Title
Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment
Time Frame
Within 240 minutes post-treatment
Title
Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment
Time Frame
Within 240 minutes post-treatment
Title
Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment
Time Frame
Within 240 minutes post-treatment
Title
Need for Rescue Medication between the time of dosing to 240 minutes
Time Frame
Within 240 minutes post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caren Behar, MD
Phone
914-584-2413
Email
ardavsa@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caren Behar, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caren Behar, MD

12. IPD Sharing Statement

Learn more about this trial

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

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