Trial Outcomes & Findings for A Pilot Study of Terazosin for Parkinson's Disease (NCT NCT03905811)

NCT ID: NCT03905811

Last Updated: 2022-05-16

Results Overview

All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-05-16

Participant Flow

Participant milestones

Measure	Active Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Overall Study STARTED	8	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Terazosin for Parkinson's Disease

Baseline characteristics by cohort

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime	Total n=13 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 6.1 • n=5 Participants	68.8 years STANDARD_DEVIATION 6.6 • n=7 Participants	66.4 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	5 Participants n=7 Participants	13 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

PRIMARY outcome

Timeframe: 12 weeks

All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.

Outcome measures

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Incidence of Intervention-related Adverse Events Between Treatment Arms	11 Event	4 Event

PRIMARY outcome

Timeframe: 12 weeks

The number of participants in each group who report a fall, as determined by the site investigator, will be reported.

Outcome measures

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Incidence of Falls Between Treatment Arms	0 Event	0 Event

PRIMARY outcome

Timeframe: 12 weeks

The number of participants in each group who drop out of the study for any reason will be compared.

Outcome measures

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At Baseline, 2 weeks, 6 weeks, and 12 weeks

Population: Change in Systolic BP at 2 weeks, 6 weeks, and 12 weeks Change in Diastolic BP at 2 weeks, 6 weeks, and 12 weeks

Mean change in sitting systolic blood pressure and diastolic blood pressure from baseline reading at 2 weeks, 6 weeks, and 12 weeks. A negative number indicates a decrease in blood pressure while a positive number indicates an increase in blood pressure.

Outcome measures

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
To Assess the Mean Change in Blood Pressure Systolic at 2 weeks	-5.29 mmHg Standard Deviation 12.6	-2.20 mmHg Standard Deviation 11.5
To Assess the Mean Change in Blood Pressure Systolic at 6 weeks	-15.05 mmHg Standard Deviation 8.21	2.20 mmHg Standard Deviation 23.2
To Assess the Mean Change in Blood Pressure Systolic at 12 weeks	-11.0 mmHg Standard Deviation 16.1	-3.20 mmHg Standard Deviation 13.1
To Assess the Mean Change in Blood Pressure Diastolic at 2 weeks	-2.00 mmHg Standard Deviation 5.54	-2.20 mmHg Standard Deviation 8.87
To Assess the Mean Change in Blood Pressure Diastolic at 6 weeks	-5.29 mmHg Standard Deviation 4.54	4.20 mmHg Standard Deviation 8.14
To Assess the Mean Change in Blood Pressure Diastolic at 12 weeks	-9.40 mmHg Standard Deviation 2.07	-2.00 mmHg Standard Deviation 11.3

SECONDARY outcome

Timeframe: 12 weeks

How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.

Outcome measures

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Number of Participants With Intolerable Side Effects	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At 2 weeks, 6 weeks and 12 weeks

Population: Number of participants analyzed changes at different time points due to participant drop-out

All participants will be asked to bring their study intervention bottles to their 6 week visit and their 12 week visit so the Investigational Drug Pharmacy can count remaining pills and assess compliance based on dispensing history. A participant will be considered non-compliant if they had more than 5 missed doses during the course of the study.

Outcome measures

Measure	Active n=8 Participants Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 Participants Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Participants Demonstrating Non-Compliance Non-compliance at 2 weeks	0 Participants	0 Participants
Participants Demonstrating Non-Compliance Non-compliance at 6 weeks	0 Participants	0 Participants
Participants Demonstrating Non-Compliance Non-compliance at 12 weeks	0 Participants	0 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active n=8 participants at risk Terazosin administered 5 mg once daily p.o. for 12 weeks Terazosin 5 MG: 5 milligrams by mouth daily at bedtime	Placebo n=5 participants at risk Placebo administered once daily p.o. for 12 weeks Placebo oral capsule: 1 capsule by mouth daily at bedtime
Nervous system disorders Dizzy/Lightheadedness	87.5% 7/8 • 12 week	20.0% 1/5 • 12 week
Nervous system disorders Unsteady	12.5% 1/8 • 12 week	40.0% 2/5 • 12 week
Nervous system disorders Headache	12.5% 1/8 • 12 week	20.0% 1/5 • 12 week
Nervous system disorders Fatigue	12.5% 1/8 • 12 week	0.00% 0/5 • 12 week
Nervous system disorders Orthostatic Hypotension	25.0% 2/8 • 12 week	0.00% 0/5 • 12 week

Additional Information

Jordan Schultz

University of Iowa

Phone: 3193849388

Email: jordan-schultz@uiowa.edu

Results disclosure agreements

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