A Randomized, Double-Blinded, Placebo-Controlled, Cross Over Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine
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|ClinicalTrials.gov Identifier: NCT03836664|
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Timolol Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blinded, Placebo-Controlled, Cross Over Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine|
|Actual Study Start Date :||February 27, 2017|
|Actual Primary Completion Date :||April 14, 2018|
|Actual Study Completion Date :||April 14, 2018|
Experimental: Group 1: Timolol
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.
Timolol is a clear solution supplied in a plastic ophthalmic dispenser.
Other Name: 0.5% timolol ophthalmic solution
Placebo Comparator: Group 2: Placebo
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.
Placebo is normal saline solution that will be supplied in container matched to Timolol container.
- Headache severity [ Time Frame: headache severity at 120 minutes post intervention use ]Measure of the change in severity using pain relief scale. Scale will be completed after each migraine over course of participation in study, up to 8 weeks.
- Safety of using Timolol [ Time Frame: 8 weeks ]Measured by count of adverse events experienced by study participants
- Subject satisfaction with Intervention [ Time Frame: 8 weeks ]Measured by patient-reported satisfaction questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836664
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dipika Aggarwal, MD||University of Kansas Medical Center|