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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Behar, Caren, M.D..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228552
First Posted: October 26, 2010
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Behar, Caren, M.D.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.

Condition Intervention Phase
Migraine Disorders Migraine Headache Migraine Acute Migraine Drug: Topical, intra-oral ketoprofen gel Other: Placebo gel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Behar, Caren, M.D.:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • 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 ]
  • Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ]
  • Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ]
  • Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ]
  • Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment [ Time Frame: Within 240 minutes post-treatment ]
  • Need for Rescue Medication between the time of dosing to 240 minutes [ Time Frame: Within 240 minutes post-treatment ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical, intra-oral ketoprofen gel 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.
Placebo Comparator: Placebo gel 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228552


Contacts
Contact: Caren Behar, MD 914-584-2413 ardavsa@aol.com

Locations
United States, New York
New York Medical College Not yet recruiting
Valhalla, New York, United States, 10595
Principal Investigator: Caren Behar, MD         
Sponsors and Collaborators
Behar, Caren, M.D.
Investigators
Principal Investigator: Caren Behar, MD New York Medical College
  More Information

Responsible Party: Behar, Caren M.D., New York Medical College
ClinicalTrials.gov Identifier: NCT01228552     History of Changes
Other Study ID Numbers: 79,629
First Submitted: October 25, 2010
First Posted: October 26, 2010
Last Update Posted: June 8, 2011
Last Verified: October 2010

Keywords provided by Behar, Caren, M.D.:
Acute Migraine Treatment
Migraine Treatment
Migraine
Headache
Treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action