Trial Outcomes & Findings for A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine (NCT NCT03836664)
NCT ID: NCT03836664
Last Updated: 2019-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Headache/ pain severity at onset and at 120 minutes post intervention use
Results posted on
2019-07-02
Participant Flow
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.
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.
Participant milestones
| Measure |
Timolol Intervention (2hours), no Washout, Placebo (2 Hours)
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.
|
Placebo (2 Hours), no Washout, Timolol (2 Hours)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Timolol Intervention (2hours), no Washout, Placebo (2 Hours)
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.
|
Placebo (2 Hours), no Washout, Timolol (2 Hours)
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.
|
|---|---|---|
|
Overall Study
Didn't complete forms and lost drug
|
3
|
3
|
Baseline Characteristics
A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Timolol Intervention (2 Hours), Followed by Placebo (2 Hours)
n=14 Participants
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.
|
Placebo (2 Hours), Followed by Timolol Intervention (2 Hours)
n=11 Participants
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
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Headache/ pain severity at onset and at 120 minutes post intervention usePopulation: All participants
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.
Outcome measures
| Measure |
All Participants Post Timolol
n=19 Participants
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.
|
All Participants Post Placebo
n=19 Participants
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.
|
|---|---|---|
|
Headache Severity
|
2.00 score on a scale
Interval 1.04 to 2.96
|
2.00 score on a scale
Interval 0.72 to 3.07
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: total number of adverse events in each group
Measured by number of adverse events experienced by the participants from the intervention. Each adverse event was counted as one.
Outcome measures
| Measure |
All Participants Post Timolol
n=19 Participants
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.
|
All Participants Post Placebo
n=19 Participants
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.
|
|---|---|---|
|
Adverse Reaction From Using Timolol Eye Drops
|
2 events
|
3 events
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All participants
Measured by patient-reported satisfaction questionnaire. Satisfaction level was looked at as "satisfactory and very satisfactory" compared to "neutral and unsatisfied".
Outcome measures
| Measure |
All Participants Post Timolol
n=19 Participants
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.
|
All Participants Post Placebo
n=19 Participants
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.
|
|---|---|---|
|
Number of Participants Satisfied With Intervention
|
3 Participants
|
6 Participants
|
Adverse Events
All Participants Post Timolol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
All Participants Post Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants Post Timolol
n=19 participants at risk
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.
|
All Participants Post Placebo
n=19 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Eyes burning/ stinging
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected within 1 day of drug administration. All participants were advised to report any adverse event within 24 hours.
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.
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected within 1 day of drug administration. All participants were advised to report any adverse event within 24 hours.
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.
|
Additional Information
Dr Dipika Aggarwal, Clinical Assistant Professor
University of Kansas Medical Center
Phone: 9139459926
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place