NCT02630719

Brief Summary

The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 25, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 15, 2019

Completed
Last Updated

May 15, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

November 25, 2015

Results QC Date

November 18, 2018

Last Update Submit

April 22, 2019

Conditions

Migraine

Keywords

headache

Outcome Measures

Primary Outcomes (1)

  • Timolol Eye Drops in the Treatment of Acute Migraine Headache

    Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society: 0: no headache 1. mild headache 2. moderate headaches 3. severe headache

    4 months

Study Arms (2)

Timolol eye drops

ACTIVE COMPARATOR

All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study.

Drug: Timolol eye drops

Artificial tears

PLACEBO COMPARATOR

All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study.

Drug: Artificial tears

Interventions

Timolol eye dropsDRUG

eye drops

Timolol eye drops
Artificial tearsDRUG

Placebo drop

Artificial tears

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of migraine headache

You may not qualify if:

  • Non-migraine headache
  • Use of systemic beta-blocker
  • Medical history of hypotension, bradycardia, syncope or other significant cardiovascular disease
  • Medical history of difficulty breathing, asthma or chronic obstructive pulmonary disease or other pulmonary disease
  • Medical history of glaucoma, ocular hypertension or hypotony, punctual stenosis, current use of other ophthalmic medications
  • Previous adverse reaction to timolol or other beta-blockers
  • Inability to self-administer eye drop due to physical or cognitive disorders
  • Currently pregnant or breastfeeding
  • Pregnant in the past year
  • Non-english speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • Cossack M, Nabrinsky E, Turner H, Abraham A, Gratton S. Timolol Eyedrops in the Treatment of Acute Migraine Attacks: A Randomized Crossover Study. JAMA Neurol. 2018 Aug 1;75(8):1024-1025. doi: 10.1001/jamaneurol.2018.0970.

    PMID: 29799915DERIVED

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Results Point of Contact

Title
Sean Gratton MD
Organization
Truman Medical Center
sean.gratton@tmemed.org
816-404-5275

Study Officials

  • Sean Gratton, MD

    UMKC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Staff Physician

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 15, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 15, 2019

Results First Posted

May 15, 2019

Record last verified: 2019-04

Locations

US(1)