The TZ-PD trial will be a 1:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and tolerability of terazosin for the treatment of PD.
This will be a single center, randomized, double-blind, controlled, pilot study to assess the safety and tolerability of terazosin (TZ) at a dose of 5 milligrams (MG) daily for patients with PD. The primary goal of this study is to assess the safety and tolerability of TZ in patients with PD. This is a pilot study and is not powered to assess efficacy of this medication. Our hope is that this study will guide future studies of this (and similar) medications for the disease modification of PD. This study is also aimed to learn more about how patients with produce and use energy and if TZ can help to reverse energy deficits that appear in PD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13
5 milligrams by mouth daily at bedtime
1 capsule by mouth daily at bedtime
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Incidence of Intervention-related Adverse Events Between Treatment Arms
All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.
Time frame: 12 weeks
Incidence of Falls Between Treatment Arms
The number of participants in each group who report a fall, as determined by the site investigator, will be reported.
Time frame: 12 weeks
Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason
The number of participants in each group who drop out of the study for any reason will be compared.
Time frame: 12 weeks
To Assess the Mean Change in Blood Pressure
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.
Time frame: At Baseline, 2 weeks, 6 weeks, and 12 weeks
Number of Participants With Intolerable Side Effects
How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.
Time frame: 12 weeks
Participants Demonstrating Non-Compliance
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.
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Time frame: At 2 weeks, 6 weeks and 12 weeks