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Topical Bimatoprost in the Treatment of Migraine

Primary Purpose

Migraine Disorders, Headache Disorders

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bimatoprost Topical Solution

Control

About this trial

This is an interventional prevention trial for Migraine Disorders focused on measuring migraine, headache, bimatoprost

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.

Exclusion Criteria:

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,
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.

Sites / Locations

CTI Clinical Trial and Consulting Services
Omega Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bimatoprost Topical Solution

Control

Arm Description

0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks

Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks

Outcomes

Primary Outcome Measures

Reduction in Headache Frequency

Change from baseline in the average number of headache days per month

Secondary Outcome Measures

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)

Duration of Headaches

Change from baseline in the average duration of headaches

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.

Full Information

NCT ID

NCT03419715

First Posted

January 23, 2018

Last Updated

April 25, 2019

Sponsor

Manistee Partners

1. Study Identification

Unique Protocol Identification Number

NCT03419715

Brief Title

Topical Bimatoprost in the Treatment of Migraine

Official Title

A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 5, 2018 (Actual)

Primary Completion Date

April 25, 2019 (Actual)

Study Completion Date

June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Manistee Partners

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Disorders, Headache Disorders

Keywords

migraine, headache, bimatoprost

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bimatoprost Topical Solution

Arm Type

Experimental

Arm Description

0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Bimatoprost Topical Solution

Other Intervention Name(s)

Lumigan

Intervention Description

One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed

Intervention Type

Drug

Intervention Name(s)

Control

Other Intervention Name(s)

placebo

Intervention Description

One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.

Primary Outcome Measure Information:

Title

Reduction in Headache Frequency

Description

Change from baseline in the average number of headache days per month

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Intensity of Headaches

Description

Change from baseline in the average intensity of headaches on a scale of 0 (no pain at all) to 10 (life-threatening pain)

Time Frame

12 weeks

Title

Duration of Headaches

Description

Change from baseline in the average duration of headaches

Time Frame

12 weeks

Title

Migraine Disability Assessment Scale (MIDAS)--Quality of Life

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month. Exclusion Criteria: 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, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert L Bratzler, PhD

Organizational Affiliation

Manistee Partners

Official's Role

Study Chair

Facility Information:

Facility Name

CTI Clinical Trial and Consulting Services

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212

Country

United States

Facility Name

Omega Medical Research

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

result

Learn more about this trial

Topical Bimatoprost in the Treatment of Migraine

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