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A Randomized 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
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Timolol
Drug: Placebo
Enrollment 25
Recruitment Details A total of 26 participants in the age group of 18-65 years were recruited from the general neurology clinics at the University of Kansas Medical Center. One participant did not meet inclusion criteria and was excluded from the study. Finally 25 participants were enrolled. Recruitment period ended from 4/21/17 to 2/23/18.
Pre-assignment Details Out of the 26 recruited participants, upon screening one participant no more met inclusion criteria due to worsening of his clinical condition. He had an increase in his migraine frequency and therefore, did not meet the inclusion criteria of 1-8 migraine episodes per month. He was considered to be a screen fail and was not enrolled in the study.
Arm/Group Title Timolol Intervention (2hours), no Washout, Placebo (2 Hours) Placebo (2 Hours), no Washout, Timolol (2 Hours)
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Participants were randomized to either Timolol/placebo group or placebo/Timolol group.

Migraine 1: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They will put 2 drops of the solution in each eye after migraine onset and again 2 hours later if needed or headache persists.

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

There was no washout period.

Migraine 2: Participants were given matching placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine onset and then again 2 hours later if needed or if headache persisted.

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

Participants were randomized to either Timolol/placebo group or placebo/Timolol group.

Migraine 1: Participants were given placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

There was no washout period.

Migraine 2: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They put 2 drops of solution in each eye after migraine onset and then again 2 hours later if needed or if headache persisted.

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

Period Title: Overall Study
Started 14 11
Completed 11 8
Not Completed 3 3
Reason Not Completed
Didn't complete forms and lost drug             3             3
Arm/Group Title Timolol Intervention (2 Hours), Followed by Placebo (2 Hours) Placebo (2 Hours), Followed by Timolol Intervention (2 Hours) Total
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Participants were randomized to either Timolol/placebo group or placebo/Timolol group.

Migraine 1: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They will put 2 drops of the solution in each eye after migraine onset and again 2 hours later if needed or headache persists.

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

There was no washout period.

Migraine 2: Participants were given matching placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine onset and then again 2 hours later if needed or if headache persisted.

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

Participants were randomized to either Timolol/placebo group or placebo/Timolol group.

Migraine 1: Participants were given matching placebo (0.9% normal saline solution) to use after migraine onset. They put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

There was no washout period.

Migraine 2: Participants were given 0.5% timolol ophthalmic solution to use after migraine onset. They put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.

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

Total of all reporting groups
Overall Number of Baseline Participants 14 11 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
11
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
Female
13
  92.9%
10
  90.9%
23
  92.0%
Male
1
   7.1%
1
   9.1%
2
   8.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 14 11 25
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 11 participants 25 participants
14 11 25
1.Primary Outcome
Title Headache Severity
Hide Description 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.
Time Frame Headache/ pain severity at onset and at 120 minutes post intervention use
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Hide Analysis Population Description
All participants
Arm/Group Title All Participants Post Timolol All Participants Post Placebo
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Participants given 0.5% timolol ophthalmic solution to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later.

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

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

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

Overall Number of Participants Analyzed 19 19
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
2.00
(1.04 to 2.96)
2.00
(0.72 to 3.07)
2.Secondary Outcome
Title Adverse Reaction From Using Timolol Eye Drops
Hide Description Measured by number of adverse events experienced by the participants from the intervention. Each adverse event was counted as one.
Time Frame 8 weeks
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Hide Analysis Population Description
total number of adverse events in each group
Arm/Group Title Total Number of Adverse Events Post Timolol Intervention Total Number of Adverse Events Post Placebo
Hide Arm/Group Description:

Participants given 0.5% timolol ophthalmic solution to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.

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

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

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: events
2 3
3.Secondary Outcome
Title Number of Participants Satisfied With Intervention
Hide Description Measured by patient-reported satisfaction questionnaire. Satisfaction level was looked at as "satisfactory and very satisfactory" compared to "neutral and unsatisfied".
Time Frame 8 weeks
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Hide Analysis Population Description
All participants
Arm/Group Title Number of Participants Satisfied Post Timolol Intervention Number of Participants Satisfied Post Placebo
Hide Arm/Group Description:

Participants given 0.5% timolol ophthalmic solution to use after migraine onset. Participants put 2 drops of solution in each eye after migraine and then again 2 hours later if needed or if headache persisted.

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

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

Placebo: Placebo is normal saline solution supplied in container matched to Timolol container.

Overall Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.8%
6
  31.6%
Time Frame Adverse event data was collected within 1 day of drug administration. All participants were advised to report any adverse event within 24 hours.
Adverse Event Reporting Description Participants were advised to call with minor side effects/ adverse events within 24 hours, and go to nearest ER in case of any serious adverse event.
 
Arm/Group Title All Participants Post Timolol All Participants Post Placebo
Hide Arm/Group Description

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 if needed or headache persists.

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

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 if needed or headache persists.

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

All-Cause Mortality
All Participants Post Timolol All Participants Post Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants Post Timolol All Participants Post Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants Post Timolol All Participants Post Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/19 (10.53%)      3/19 (15.79%)    
Eye disorders     
Eyes burning/ stinging * 1  2/19 (10.53%)  2 3/19 (15.79%)  3
1
Term from vocabulary, burning, stinging
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Dipika Aggarwal, Clinical Assistant Professor
Organization: University of Kansas Medical Center
Phone: 9139459926
EMail: daggarwal@kumc.edu
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03836664     History of Changes
Other Study ID Numbers: STUDY00140465
First Submitted: February 8, 2019
First Posted: February 11, 2019
Results First Submitted: April 10, 2019
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019