Migraine DisordersPhase 3NCT01228552
The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine
A Phase 3 study testing Topical, intra-oral ketoprofen gel in people with Migraine Disorders and Migraine Headache, run by Behar, Caren, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Migraine Headache, Migraine
- What is being tested?
- Topical, intra-oral ketoprofen gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Medical College
Valhalla, New York, 10595
Caren Behar, MD
About this study
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
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.
- Conditions
- Migraine Disorders, Migraine Headache, Migraine, Acute Migraine
- Being tested
- Topical, intra-oral ketoprofen gel, Placebo gel
- Keywords
- Acute Migraine Treatment, Migraine Treatment, Migraine, Headache, Treatment
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical, intra-oral ketoprofen gelDrug
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 gelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical, intra-oral ketoprofen gel | Active comparator | Not described Receives: Drug: Topical, intra-oral ketoprofen gel |
| Placebo gel | Placebo comparator | Not described Receives: Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
Measured: 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
Measured: Within 240 minutes post-treatment
Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals
Measured: Within 240 minutes post-treatment
Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment
Measured: Within 240 minutes post-treatment
Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment
Measured: Within 240 minutes post-treatment
Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment
Measured: Within 240 minutes post-treatment
Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment
Measured: Within 240 minutes post-treatment
Need for Rescue Medication between the time of dosing to 240 minutes
Measured: Within 240 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startDec 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Behar, Caren, M.D.
- Investigators
- Caren Behar, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228552
- Sponsor's protocol ID
- 79,629
- Status last verified
- Oct 2010
- First submitted
- 25 Oct 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01228552
- Acronym / sponsor ID
- 79,629
- Conditions
- Migraine Disorders, Migraine Headache, Migraine, Acute Migraine
- Keywords
- Acute Migraine Treatment, Migraine Treatment, Migraine, Headache, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Behar, Caren, M.D.
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical, intra-oral ketoprofen gel | Active comparator | Drug: Topical, intra-oral ketoprofen gel |
| Placebo gel | Placebo comparator | Other: Placebo gel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical, intra-oral ketoprofen gelKetoprofen 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. | Drug | Topical, intra-oral ketoprofen gel |
| Placebo gelPlacebo 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 |
Primary outcome
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
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
Related trials for Migraine Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caren Behar, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical, intra-oral ketoprofen gel in people with Migraine Disorders and Migraine Headache, run by Behar, Caren, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caren Behar, MD (914-584-2413, ardavsa@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.