The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJune 8, 2011
October 1, 2010
1 month
October 25, 2010
June 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Topical, intra-oral ketoprofen gel
ACTIVE COMPARATORPlacebo gel
PLACEBO COMPARATORInterventions
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 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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Medical College
Valhalla, New York, 10595, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caren Behar, MD
New York Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
October 25, 2010
First Posted
October 26, 2010
Study Start
December 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 8, 2011
Record last verified: 2010-10