Trial Outcomes & Findings for Caffeine/Propranolol Intervention for Acute Migraine (NCT NCT01080677)
NCT ID: NCT01080677
Last Updated: 2017-02-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
2 hours
Results posted on
2017-02-24
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caffeine/Propranolol Intervention for Acute Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
n=20 Participants
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
n=20 Participants
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Gender
Female
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Gender
Male
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
60 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 2 hoursOutcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
n=20 Participants
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
n=20 Participants
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
|---|---|---|---|
|
Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)
|
10 percentage of participants
|
45 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hoursOutcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
n=20 Participants
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
n=20 Participants
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
|---|---|---|---|
|
Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol
|
0 percentage of participants
|
20 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursAdverse events may have included abdominal pain, flushing, dizziness, insomnia, or anxiety
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
n=20 Participants
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
n=20 Participants
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
|---|---|---|---|
|
Percentage of Participants Experiencing at Least One Adverse Event of Interest
|
10 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursFollowing up to 24 hours after treatment, participants were asked to report whether they were satisfied with level of pain relief provided by treatment
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
n=20 Participants
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
n=20 Participants
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
|---|---|---|---|
|
Percentage of Participants With Treatment Satisfaction
|
5 percentage of participants
|
40 percentage of participants
|
80 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Participants received placebo to match caffeine/propranolol (single dose)
|
Low Dose
n=20 participants at risk
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
|
High Dose
n=20 participants at risk
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
2/20 • Number of events 2 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
|
Nervous system disorders
dizziness
|
10.0%
2/20 • Number of events 2 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
|
Nervous system disorders
insomnia
|
0.00%
0/20 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
|
Psychiatric disorders
anxiety
|
0.00%
0/20 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
|
General disorders
flushing
|
0.00%
0/20 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
5.0%
1/20 • Number of events 1 • 24 hours
|
Additional Information
Professor of Neurology
Stanford University School of Medicine
Phone: 650-723-5184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place