Trial Outcomes & Findings for Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin (NCT NCT02266329)
NCT ID: NCT02266329
Last Updated: 2024-06-26
Results Overview
Change from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) of either 1) Headaches that last 4 or more hours a day and reach a moderate to severe intensity at any point or 2) Headaches of any intensity if a medication or other treatment is used in an effort to stop the Headaches, as determined from Headache Log data.
COMPLETED
PHASE1/PHASE2
89 participants
Baseline to 12 weeks
2024-06-26
Participant Flow
166 participants completed the informed consent process, agreeing to participation. 77 of those participants failed the screening process, declined to participate prior to study drug randomization, or were lost to follow-up prior to study drug randomization. 89 participants were randomized to study drug.
Participant milestones
| Measure |
Prazosin
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
prazosin hydrochloride: Prazosin as oral capsules titrated to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
|
Placebo
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
placebo: Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.
|
|---|---|---|
|
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
Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
Baseline characteristics by cohort
| Measure |
Prazosin
n=59 Participants
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
prazosin hydrochloride: Prazosin as oral capsules titrated to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
|
Placebo
n=30 Participants
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
placebo: Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
00 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
|
|
Headache frequency
|
15.5 headaches
STANDARD_DEVIATION 6.1 • n=5 Participants
|
17.1 headaches
STANDARD_DEVIATION 6.0 • n=7 Participants
|
16.0 headaches
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) of either 1) Headaches that last 4 or more hours a day and reach a moderate to severe intensity at any point or 2) Headaches of any intensity if a medication or other treatment is used in an effort to stop the Headaches, as determined from Headache Log data.
Outcome measures
| Measure |
Prazosin
n=59 Participants
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
prazosin hydrochloride: Prazosin as oral capsules titrated to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
|
Placebo
n=30 Participants
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
placebo: Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.
|
|---|---|---|
|
Headache Diary
|
-10.7 headaches per month
Standard Error 0.9
|
-6.9 headaches per month
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) in 4-week average peak HA severity, as determined from Headache Log data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) in 4-week average total number of hours of HA pain of any severity, as determined from Headache Log data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) in 4-week average frequency of use of abortive and/or analgesic HA treatment medications, as determined from Headache Log data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) in average headache-related disability, as measured 1) in 4-week treatment intervals using the Headache Impact Test-6 and 2) in the full 12-week treatment interval using the Migraine Disability Assessment (for subjects who meet diagnostic criteria for migraine).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) in PTSD symptom severity, as measured using the PTSD Checklist (PCL) given at baseline and at 4-week treatment intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pretreatment) in sleep characteristics, including sleep quality, quantity, and efficiency using 1) the Pittsburgh Sleep Quality Index and the Insomnia Severity Index given at baseline and at 4-week treatment intervals and 2) sleep diary and wrist actigraphy performed for one week at baseline and after 11 weeks of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) in concussion-related symptoms, as measured at 4-week treatment intervals using the Neurobehavioral Symptom Inventory
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) in depressive symptoms, as measured at 4-week treatment intervals using the Patient Health Questionnaire-9.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) in alcohol use, as measured at 4-week treatment intervals using the Alcohol Use Disorders Identification Test-Consumption.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) in cognitive function, as measured at 4-week treatment intervals using the Montreal Cognitive Assessment (MoCA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) in pupillary light responses using pupillometry, as a measure of sympathetic activation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) in light sensitivity symptoms, as determined using a modified Utah Photophobia Symptom Impact Scale - 12-Item)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeksNumber of patients with a 50% or more decrease in mean number of headache days per 4 weeks, as determined at 4 week treatment intervals using Headache Log data.
Outcome measures
Outcome data not reported
Adverse Events
Prazosin
Placebo
Serious adverse events
| Measure |
Prazosin
n=59 participants at risk
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
prazosin hydrochloride: Prazosin as oral capsules titrated to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
|
Placebo
n=30 participants at risk
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
placebo: Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.
|
|---|---|---|
|
Surgical and medical procedures
Planned surgical procedure
|
1.7%
1/59 • Number of events 1 • 24 weeks
|
3.3%
1/30 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Prazosin
n=59 participants at risk
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
prazosin hydrochloride: Prazosin as oral capsules titrated to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
|
Placebo
n=30 participants at risk
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
placebo: Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
35.6%
21/59 • Number of events 23 • 24 weeks
|
20.0%
6/30 • Number of events 6 • 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
|
|
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
Drowsiness/Lethargy
|
44.1%
26/59 • Number of events 30 • 24 weeks
|
16.7%
5/30 • Number of events 5 • 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
|
|
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
Low Energy
|
27.1%
16/59 • Number of events 17 • 24 weeks
|
10.0%
3/30 • Number of events 3 • 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
Peripheral Edemna
|
18.6%
11/59 • Number of events 12 • 24 weeks
|
10.0%
3/30 • Number of events 4 • 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
Weakness (generalized)
|
10.2%
6/59 • Number of events 6 • 24 weeks
|
3.3%
1/30 • Number of events 1 • 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
|
|
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
|
|
Renal and urinary disorders
Incontinence
|
6.8%
4/59 • Number of events 4 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place