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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03905811
Recruitment Status : Completed
First Posted : April 5, 2019
Results First Posted : August 2, 2021
Last Update Posted : May 16, 2022
University of Iowa
Information provided by (Responsible Party):
Jordan Schultz, University of Iowa

Brief Summary:
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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Terazosin for Parkinson's Disease
Actual Study Start Date : September 24, 2019
Actual Primary Completion Date : June 5, 2020
Actual Study Completion Date : November 18, 2020

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Placebo

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 :
  1. To Assess the Mean Change in Blood Pressure [ Time Frame: At Baseline, 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.

  2. Number of Participants With Intolerable Side Effects [ Time Frame: 12 weeks ]
    How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.

  3. Participants Demonstrating Non-Compliance [ Time Frame: At 2 weeks, 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. A participant will be considered non-compliant if they had more than 5 missed doses during the course of the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905811

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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Jordan Schultz
University of Iowa
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Principal Investigator: Jordan Schultz, PharmD University of Iowa
Principal Investigator: Nandakumar Narayanan, MD, PhD University of Iowa
  Study Documents (Full-Text)

Documents provided by Jordan Schultz, University of Iowa:
Informed Consent Form  [PDF] February 22, 2022

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Responsible Party: Jordan Schultz, PharmD, University of Iowa
ClinicalTrials.gov Identifier: NCT03905811    
Other Study ID Numbers: 201902772
First Posted: April 5, 2019    Key Record Dates
Results First Posted: August 2, 2021
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: One year after completion of this study
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.

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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
Keywords provided by Jordan Schultz, University of Iowa:
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents