Terazosin for Parkinson's Disease (TZ-PD)
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|ClinicalTrials.gov Identifier: NCT03905811|
Recruitment Status : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : September 17, 2019
University of Iowa
Information provided by (Responsible Party):
Jordan Schultz, University of Iowa
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Terazosin 5 MG Drug: Placebo oral capsule||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Pilot Study of Terazosin for Parkinson's Disease|
|Estimated Study Start Date :||September 23, 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||January 2020|
Terazosin administered 5 mg once daily p.o. for 12 weeks
Drug: Terazosin 5 MG
5 milligrams by mouth daily at bedtime
Placebo Comparator: Placebo
Placebo administered once daily p.o. for 12 weeks
Drug: Placebo oral capsule
1 capsule by mouth daily at bedtime
Primary Outcome Measures :
- Incidence of intervention-related adverse events between treatment arms [ Time Frame: 12 weeks ]All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.
- Incidence of falls between treatment arms [ Time Frame: 12 weeks ]The number of participants in each group who report a fall, as determined by the site investigator, will be reported.
- To assess the mean change in systolic and diastolic blood pressures [ Time Frame: At 6 weeks and 12 weeks ]
- Frequency of drop-out from study/discontinuation of study intervention for any reason [ Time Frame: 12 weeks ]The number of participants in each group who drop out of the study for any reason will be compared.
Secondary Outcome Measures :
- Mean change in systolic and diastolic blood pressure [ Time Frame: From baseline to 6 weeks and 12 weeks ]
- Prevalence of falls between placebo and active group [ Time Frame: 12 weeks ]
- Prevalence of intolerable side effects between placebo and active group [ Time Frame: 12 weeks ]
- Prevalence of study discontinuation between placebo and active group [ Time Frame: 12 weeks ]
- Differences in overall compliance between placebo and active group as assessed by pill counts [ Time Frame: At 6 weeks and 12 weeks ]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.
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