Migraine DisordersPhase 2NCT03419715
Topical Bimatoprost in the Treatment of Migraine
A Phase 2 study testing Bimatoprost Topical Solution in people with Migraine Disorders and Headache Disorders, run by Manistee Partners at 2 sites in United States.
Trial summary
The study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders, Headache Disorders
- What is being tested?
- Bimatoprost Topical Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2018to 30 Jun 2019
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.
Who cannot join
- Significant liver or renal dysfunction,
- On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria,
- Use of antipsychotics in the past month,
- Recent (in the past six months) history of alcohol or drug abuse,
- Allergy to bimatoprost and its compounds,
- Severe comorbid psychiatric illness,
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- Severe infection,
- Malignancy,
- Severe cardiovascular disease,
- Neurodegenerative disorders,
- Pregnancy and lactation, and
- Sexually active women of child bearing age who do not use any method of contraception.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
The study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life.
Read the detailed description
Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).
This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.
- Conditions
- Migraine Disorders, Headache Disorders
- Being tested
- Bimatoprost Topical Solution, Control
- Keywords
- migraine, headache, bimatoprost
- Medical subject headings
- Migraine Disorders, Headache Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost Topical SolutionDrug
Also called Lumigan
One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
ControlDrug
Also called placebo
One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost Topical Solution | Experimental | 0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks Receives: Drug: Bimatoprost Topical Solution |
| Control | Placebo comparator | Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Headache Frequency
Change from baseline in the average number of headache days per month
Measured: 12 weeks
Secondary outcomes (3)
Intensity of Headaches
Change from baseline in the average intensity of headaches on a scale of 0 (no pain at all) to 10 (life-threatening pain)
Measured: 12 weeks
Duration of Headaches
Change from baseline in the average duration of headaches
Measured: 12 weeks
Migraine Disability Assessment Scale (MIDAS)--Quality of Life
Change from baseline in quality of life as measured by the Migraine Disability Assessment Scale (MIDAS). MIDAS is a five-item instrument developed to measure migraine related disability and functional consequences. It is divided into four categories based on the score of: 0-5, minimal disability; 6-10, mild disability; 11-20, moderate disability; greater than 20; severe disability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Jan 2018
- Primary completion25 Apr 2019
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manistee Partners
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L Bratzler, PhD, Study chair, Manistee Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419715
- Sponsor's protocol ID
- 17-MAN-001
- Status last verified
- Apr 2019
- First submitted
- 23 Jan 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hall LB et al. The Effect of Topical Prostaglandins on Migraine Headaches. Poster Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting, May 2017.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT03419715
- Acronym / sponsor ID
- 17-MAN-001
- Conditions
- Migraine Disorders, Headache Disorders
- Keywords
- migraine, headache, bimatoprost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Manistee PartnersIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 5 Feb 2018 (actual)
- 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 study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life.
Detailed description
Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).
This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost Topical Solution | Experimental | Drug: Bimatoprost Topical Solution0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks |
| Control | Placebo comparator | Drug: ControlSaline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.
Key exclusion criteria (12 listed)
- Significant liver or renal dysfunction,
- On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria,
- Use of antipsychotics in the past month,
- Recent (in the past six months) history of alcohol or drug abuse,
- Allergy to bimatoprost and its compounds,
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 |
|---|---|---|
| Bimatoprost Topical SolutionAlso: LumiganOne drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed | Drug | Bimatoprost Topical Solution |
| ControlAlso: placeboOne drop of saline solution is applied daily to the lunula of the fingernail bed on one hand. | Drug | Control |
Primary outcome
Reduction in Headache Frequency
Time frame: 12 weeks
Change from baseline in the average number of headache days per month
3 secondary outcomes
Intensity of Headaches
Time frame: 12 weeks
Duration of Headaches
Time frame: 12 weeks
Migraine Disability Assessment Scale (MIDAS)--Quality of Life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Results publicationHall LB et al. The Effect of Topical Prostaglandins on Migraine Headaches. Poster Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting, May 2017.
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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.
Robert L Bratzler, PhD study chair
Manistee Partners
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimatoprost Topical Solution in people with Migraine Disorders and Headache Disorders, run by Manistee Partners at 2 sites 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 1 inclusion and 12 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Headache Frequency (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419715, which also lists 1 linked publication.
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 26 Apr 2019.