A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine

NCT03836664 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00140465
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy (headache freedom at 2 hours) of Timolol 0.5% ophthalmic solution compared to placebo in acute treatment of migraine headache. And to assess the safety and tolerability of Timolol 0.5% ophthalmic solution in treatment of acute migraine headache.

Conditions

Migraine

Keywords

Headache; Acute migraine headache

Outcome Measures

Primary Outcomes (1)

• Headache Severity

  Measure of the change in severity using visual analogue pain scale ranging from 0-10 with zero being no pain and ten being worst pain. Scale will be completed after each migraine episode over course of participation in study, up to 8 weeks.

  Headache/ pain severity at onset and at 120 minutes post intervention use

Secondary Outcomes (2)

• Adverse Reaction From Using Timolol Eye Drops

  8 weeks

• Number of Participants Satisfied With Intervention

  8 weeks

Study Arms (2)

Group 1: Timolol

EXPERIMENTAL

Participants will be given 0.5% timolol ophthalmic solution to use after migraine onset. Participants will put 2 drops of solution in each eye after migraine and then again 2 hours later.

Drug: Timolol

Group 2: Placebo

PLACEBO COMPARATOR

Participants will be given matching placebo (0.9% normal saline solution) to use after migraine onset. Participants will put 2 drops of solution in each eye after migraine and then again 2 hours later.

Drug: Placebo

Interventions

Timolol DRUG

Timolol is a clear solution supplied in a plastic ophthalmic dispenser.

Also known as: 0.5% timolol ophthalmic solution, beta blocker eye drops

Group 1: Timolol

Placebo DRUG

Placebo is normal saline solution that will be supplied in container matched to Timolol container.

Also known as: inactive drug

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of migraine, with or without aura, according to ICHD-2 criteria (Appendix A) for at least 1 year prior to screening; experience an average of 1 to 8 migraines per month.
• Females must be practicing an effective method of birth control before entry and throughout the study, or be surgically sterile, or be postmenopausal
• Females of child-bearing potential must have a negative urine pregnancy test
• Subjects should be able to demonstrate the ability to properly administer study medication
• Subjects should be able and willing to read and comprehend written instructions and complete the diary information required by the protocol
• Subjects must be capable, in the opinion of the Investigator, of providing informed consent or assent to participate in the study
• Subjects (and their legally acceptable representatives, if applicable) must provide an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

• Inability to distinguish other headaches from migraine
• Experiences headache of any kind at a frequency greater than or equal to 15 days per month
• Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
• Chronic opioid therapy for headaches (\> 3 consecutive days in the 30 days prior to screening)
• Hemiplegic migraine
• History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
• History of glaucoma and/or current treatment with prescription eye drops
• History of naso-lacrimal duct ("tear duct problem" to patients) obstruction or surgery for such
• Active treatment by ophthalmologist or optometrist for any severe ophthalmic disease or problem
• Any physical problems or co-ordination difficulty or eye avoidance sensitivity ("squeezer") that would preclude proper installation of eye drops in either or both eyes
• History of uncontrolled asthma, COPD, or reversible airway disease which in the opinion of the investigator would be worsened by the use of beta blockers
• History of clinically symptomatic bradycardia, congestive heart failure, or hypotension
• Uncontrolled Diabetes Mellitus
• Uncontrolled Hyperthyroidism
• History (within 2 years) of drug or alcohol abuse

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Timolol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Limitations and Caveats

Participant compliance was also found to be a big limitation with 6 participants considered as study drop outs since they did not return study drug/ forms even after repeated attempts to contact them. This led to loss of data.

Results Point of Contact

• Title: Dr Dipika Aggarwal, Clinical Assistant Professor
• Organization: University of Kansas Medical Center

daggarwal@kumc.edu

9139459926

Study Officials

• Dipika Aggarwal, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 11, 2019
• Study Start: February 27, 2017
• Primary Completion: April 14, 2018
• Study Completion: April 14, 2018
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-07

Locations

US (1)