A Pilot Study of Terazosin for Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Terazosin for Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Terazosin 5 MG
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 40 and older with the diagnosis of idiopathic PD per UK Brain Bank criteria Hoehn-Yahr Stage I-III, on stable dopaminergic treatment regimen for ≥4 weeks prior to baseline. Exclusion Criteria: Subjects unwilling or unable to give informed consent Secondary parkinsonism (e.g., drug induced) Parkinson-plus syndromes History of brain surgery for PD such as deep brain stimulation No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days. Neurogenic orthostatic hypotension defined as symptomatic decrease in BP > 20mmHg systolic or > 10mmHg diastolic and HR increase < 20bpm on supine to sitting or standing. Clinically significant traumatic brain injury or post-traumatic stress disorder Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study Presence of dementia per Movement Disorder Society Level I criteria Major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neuropathy assessment in the opinion of the responsible site principal investigator. Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit Current suicidal ideation within one year prior to the baseline visit as evidenced by answering yes to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit. History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit Use of investigational drugs within 30 days before screening Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit Use of doxazosin, alfuzosin, prazosin, or tamsulosin For female participant, pregnancy, or plans for child-bearing during study period Participant is restricted from traveling to and from the study site

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Terazosin administered 5 mg once daily p.o. for 12 weeks | Drug: Terazosin 5 MG<br>* 5 milligrams by mouth daily at bedtime<br>* Other names: Hytrin;|
| Placebo Comparator: Placebo<br>Placebo administered once daily p.o. for 12 weeks | Drug: Placebo oral capsule<br>* 1 capsule by mouth daily at bedtime<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | At 2 weeks, 6 weeks and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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terazosin