A Pilot Study of Terazosin for Parkinson's Disease (TZ-PD)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Terazosin 5 MG; Drug: Placebo oral capsule

Detailed Description

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
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jordan Schultz
• Collaborators: University of Iowa
• Investigators: Principal Investigator: Jordan Schultz, PharmD, University of Iowa; Principal Investigator: Nandakumar Narayanan, MD, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): June 5, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: terazosin
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Terazosin
• Other Study ID Numbers: 201902772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
• IPD Sharing Time Frame: One year after completion of this study
• IPD Sharing Access Criteria: Qualified researchers may contact the PI of this study with reasonable requests for data to be shared. Inquiries must include what hypothesis the researcher intends to test using the shared data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes