Trial Outcomes & Findings for Prazosin and Cerebrospinal Fluid (CSF) Biomarkers in Mild Traumatic Brain Injury (mTBI) (NCT NCT03221751)

NCT ID: NCT03221751

Last Updated: 2024-02-26

Results Overview

an established biomarker of neurodegeneration in Alzheimer's disease.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 9 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2024-02-26

Participant Flow

Nine subjects were consented to participate. Two subjects completed all baseline procedures and were randomized to study drug.

Participant milestones

Measure	Prazosin Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Prazosin Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.
Overall Study lumbar puncture not performed at early termination.	1	0

Baseline Characteristics

Prazosin and Cerebrospinal Fluid (CSF) Biomarkers in Mild Traumatic Brain Injury (mTBI)

Baseline characteristics by cohort

Measure	Prazosin n=1 Participants Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo n=1 Participants Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.	Total n=2 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
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	52 years n=93 Participants	39 years n=4 Participants	45.5 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: The one prazosin participant did not under a lumbar puncture at the study termination visit.

an established biomarker of neurodegeneration in Alzheimer's disease.

Outcome measures

Measure	Prazosin Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo n=1 Participants Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.
Change in CSF Total-tau From Baseline to End of Study (pg/mL)	—	11 pg/mL

PRIMARY outcome

Timeframe: 10 weeks

Population: The one prazosin participant did not under a lumbar puncture at the study termination visit.

an established biomarker of neurodegeneration in Alzheimer's disease.

Outcome measures

Measure	Prazosin Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo n=1 Participants Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.
Change in p-tau181 From Baseline to End of Study (pg/mL)	—	2.3 pg/mL

PRIMARY outcome

Timeframe: 10 weeks

Population: The one prazosin participant did not under a lumbar puncture at the study termination visit.

an established biomarker of neurodegeneration in Alzheimer's disease.

Outcome measures

Measure	Prazosin Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo n=1 Participants Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.
Change in Amyloid Beta 42 From Baseline to End of Study (pg/mL)	—	235 pg/mL

Adverse Events

Prazosin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prazosin n=1 participants at risk Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. prazosin hydrochloride: Prazosin is an oral capsule. It is an alpha-1 antagonists.	Placebo n=1 participants at risk Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime. placebo: Placebo is an inert oral capsule identical in appearance to prazosin capsules.
Endocrine disorders adrenal insufficiency	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	100.0% 1/1 • Number of events 1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
Psychiatric disorders depressed mood	100.0% 1/1 • Number of events 1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders headache	100.0% 1/1 • Number of events 2 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders insomnia	100.0% 1/1 • Number of events 1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders lack of energy	100.0% 1/1 • Number of events 1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders lightheadedness	100.0% 1/1 • Number of events 2 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders nasal congestion	100.0% 1/1 • Number of events 1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders pain from root canal	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	100.0% 1/1 • Number of events 1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.
General disorders weakness	0.00% 0/1 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.	100.0% 1/1 • Number of events 2 • 10 weeks 14 common potential adverse symptoms of prazosin were queried at every visit as well as an open ended query for other symptoms.

Additional Information

Hollie Holmes

VA Puget Sound Health Care System

Phone: 206-277-6207

Email: Hollie.Holmes@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place