Trial Outcomes & Findings for Timolol Eye Drops in the Treatment of Acute Migraine Headache (NCT NCT02630719)
NCT ID: NCT02630719
Last Updated: 2019-05-15
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
4 months
Results posted on
2019-05-15
Participant Flow
Participant milestones
| Measure |
Timolol Eye Drops First
Timolol ophthalmic solution 0.5% first, then Artificial Tears
Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.
Each intervention period is 2 months with a 4 day washout period in between.
|
Artificial Tears First
Artificial tears first, then timolol ophthalmic solution 0.5%
Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.
Each intervention period is 2 months with a 4 day washout period in between.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Baseline characteristics by cohort
| Measure |
Timolol Eye Drops First
n=4 Participants
Treatment with timolol eye drops at the onset of an acute migraine headache for the first 2 months, then a 4 day washout period, followed by Artificial tears at the onset of an acute migraine headache for the next 2 months.
Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.
|
Artifical Tears First
n=6 Participants
Treatment with artificial eye drops at the onset of an acute migraine headache for the first 2 months, then a 4 day washout period, followed by timolol eye drops at the onset of an acute migraine headache for the next 2 months.
Subjects instill one drop of the solution at the onset of headache into both eyes. Subjects may repeat with one more drop into each eye after 30 minutes.
|
Total
n=10 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (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
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPercent 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
Outcome measures
| Measure |
Timolol Eye Drops
n=10 Participants
Treatment with timolol eye drops at the onset of an acute migraine headache
Timolol eye drops: eye drops
|
Artificial Tears
n=10 Participants
Treatment with artificial eye drops at the onset of an acute migraine headache
Artificial tears: Placebo drop
|
|---|---|---|
|
Timolol Eye Drops in the Treatment of Acute Migraine Headache
|
78 percentage of migraine attacks at 0 or 1
Standard Deviation 31
|
67 percentage of migraine attacks at 0 or 1
Standard Deviation 30
|
Adverse Events
Timolol Eye Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artificial Tears
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place