Trial Outcomes & Findings for Prazosin for Post-Concussive Headaches (NCT NCT02965027)
NCT ID: NCT02965027
Last Updated: 2024-07-10
Results Overview
Headache log completed by participant to capture number of headaches experienced.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
89 participants
Primary outcome timeframe
baseline, 4,8, and 12 weeks after steady dose
Results posted on
2024-07-10
Participant Flow
Participant milestones
| Measure |
Prazosin
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
Placebo capsules
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
30
|
|
Overall Study
COMPLETED
|
52
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prazosin for Post-Concussive Headaches
Baseline characteristics by cohort
| Measure |
Prazosin
n=59 Participants
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
n=30 Participants
Placebo capsules
Placebo
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian Native or Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing/Unknown
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
30 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 4,8, and 12 weeks after steady doseHeadache log completed by participant to capture number of headaches experienced.
Outcome measures
| Measure |
Prazosin
n=59 Participants
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
n=30 Participants
Placebo capsules
Placebo
|
|---|---|---|
|
Change From Baseline in Headache Frequency
Baseline
|
16.4 headaches per month
Standard Error 1.2
|
18.5 headaches per month
Standard Error 1.6
|
|
Change From Baseline in Headache Frequency
Week 4 - Baseline
|
-9.2 headaches per month
Standard Error 0.9
|
-7.4 headaches per month
Standard Error 1.2
|
|
Change From Baseline in Headache Frequency
Week 8 - Baseline
|
-9.9 headaches per month
Standard Error 0.9
|
-9.1 headaches per month
Standard Error 1.2
|
|
Change From Baseline in Headache Frequency
Week 12 - Baseline
|
-10.7 headaches per month
Standard Error 0.9
|
-6.9 headaches per month
Standard Error 1.3
|
SECONDARY outcome
Timeframe: baseline, 4, 8, 12 weeks after steady doseOverall sleep quality assessed utilizing the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The seven component scores are then added to yield one "global" score with a range of 0-21 points, "0" indicating no difficulty and "21" indicating sever difficulty in all areas. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: TOTAL \< 5 associated with good sleep quality. TOTAL \> 5 associated with poor sleep quality The difference between means is shown for weeks 4, 8 and 12.
Outcome measures
| Measure |
Prazosin
n=59 Participants
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
n=30 Participants
Placebo capsules
Placebo
|
|---|---|---|
|
Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index
Week 12 - Baseline
|
-2.2 score on a scale
Standard Error 0.5
|
-0.8 score on a scale
Standard Error 0.7
|
|
Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index
Baseline
|
12.1 score on a scale
Standard Error 0.6
|
12.0 score on a scale
Standard Error 0.8
|
|
Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index
Week 4 - Baseline
|
-1.0 score on a scale
Standard Error 0.5
|
0.1 score on a scale
Standard Error 0.7
|
|
Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index
Week 8 - Baseline
|
-1.9 score on a scale
Standard Error 0.5
|
-0.9 score on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: baseline, 4, 8, 12 weeks after steady doseInsomnia severity assessed using the Insomnia Severity Index (ISI). This 7-item self-report is designed to measure and detect cases of insomnia. Each question is scored on a scale of 0 to 4. The 7 items are added together. Sum scores for items 1-7 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The difference between means is shown for weeks 4, 8 and 12.
Outcome measures
| Measure |
Prazosin
n=59 Participants
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
n=30 Participants
Placebo capsules
Placebo
|
|---|---|---|
|
Insomnia Severity Index
Week 8 - Baseline
|
-3.1 score on a scale
Standard Error 0.7
|
-1.0 score on a scale
Standard Error 1.0
|
|
Insomnia Severity Index
Week 12 - Baseline
|
-3.7 score on a scale
Standard Error 0.7
|
-0.9 score on a scale
Standard Error 1.0
|
|
Insomnia Severity Index
Baseline
|
16.9 score on a scale
Standard Error 0.8
|
17.6 score on a scale
Standard Error 1.2
|
|
Insomnia Severity Index
Week 4 - Baseline
|
-3.3 score on a scale
Standard Error 0.7
|
-0.5 score on a scale
Standard Error 1.0
|
Adverse Events
Prazosin
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prazosin
n=59 participants at risk
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
n=30 participants at risk
Placebo capsules
Placebo
|
|---|---|---|
|
Surgical and medical procedures
planned surgical procedure
|
0.00%
0/59 • 24 weeks
|
3.3%
1/30 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Prazosin
n=59 participants at risk
Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime.
Prazosin
|
Placebo
n=30 participants at risk
Placebo capsules
Placebo
|
|---|---|---|
|
General disorders
Dizziness (any)
|
62.7%
37/59 • Number of events 51 • 24 weeks
|
20.0%
6/30 • Number of events 7 • 24 weeks
|
|
General disorders
Dizziness on Standing
|
40.7%
24/59 • Number of events 30 • 24 weeks
|
3.3%
1/30 • Number of events 1 • 24 weeks
|
|
General disorders
Lightheadedness
|
47.5%
28/59 • Number of events 32 • 24 weeks
|
36.7%
11/30 • Number of events 11 • 24 weeks
|
|
General disorders
Vertigo
|
1.7%
1/59 • Number of events 1 • 24 weeks
|
3.3%
1/30 • Number of events 1 • 24 weeks
|
|
General disorders
Nasal Congestion
|
32.2%
19/59 • Number of events 21 • 24 weeks
|
10.0%
3/30 • Number of events 3 • 24 weeks
|
|
General disorders
Headache worsening
|
3.4%
2/59 • Number of events 2 • 24 weeks
|
13.3%
4/30 • Number of events 5 • 24 weeks
|
|
General disorders
Drowsiness/Lethargy
|
44.1%
26/59 • Number of events 30 • 24 weeks
|
16.7%
5/30 • Number of events 5 • 24 weeks
|
|
General disorders
Low Energy
|
27.1%
16/59 • Number of events 17 • 24 weeks
|
10.0%
3/30 • Number of events 3 • 24 weeks
|
|
General disorders
Weakness (generalized)
|
10.2%
6/59 • Number of events 6 • 24 weeks
|
3.3%
1/30 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.9%
20/59 • Number of events 25 • 24 weeks
|
13.3%
4/30 • Number of events 4 • 24 weeks
|
|
Cardiac disorders
Palpitations
|
35.6%
21/59 • Number of events 23 • 24 weeks
|
20.0%
6/30 • Number of events 6 • 24 weeks
|
|
Renal and urinary disorders
Incontinence
|
6.8%
4/59 • Number of events 4 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
General disorders
Peripheral Edema
|
18.6%
11/59 • Number of events 12 • 24 weeks
|
10.0%
3/30 • Number of events 4 • 24 weeks
|
|
General disorders
Insomnia
|
13.6%
8/59 • Number of events 10 • 24 weeks
|
6.7%
2/30 • Number of events 2 • 24 weeks
|
|
Psychiatric disorders
Depression or depressed mood
|
11.9%
7/59 • Number of events 7 • 24 weeks
|
6.7%
2/30 • Number of events 2 • 24 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
5.1%
3/59 • Number of events 3 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place