NCT01211795

Brief Summary

Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

September 27, 2010

Last Update Submit

June 4, 2011

Conditions

Migraine

Keywords

MigrainePreventionTreatmentKetoprofenTrigeminal nerve

Outcome Measures

Primary Outcomes (1)

  • Change in number of migraine days per month

    Number of migraine days per month will be compared before gel use and at the end of 3 months of use.

    3 months

Secondary Outcomes (3)

  • Change in migraine severity

    3 month total

  • Change in migraine duration

    3 months

  • Change in headache medication use

    3 months

Study Arms (2)

Topical Ketoprofen gel

ACTIVE COMPARATOR
Drug: topical intraoral ketoprofen gel

Placebo gel

PLACEBO COMPARATOR
Other: Placebo Gel

Interventions

topical intraoral ketoprofen gelDRUG

20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.

Topical Ketoprofen gel
Placebo GelOTHER

An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.

Placebo gel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IHS Migraine with or without aura
  • y.o. or older
  • at least 4 migraines per month

You may not qualify if:

  • pregnancy
  • other headache conditions
  • chronic daily headache
  • allergy or sensitivity to NSAIDs other severe illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Caren Behar, MD

    New York Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 30, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(1)