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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Terazosin 5 MG

Placebo oral capsule

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring terazosin

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Terazosin administered 5 mg once daily p.o. for 12 weeks

Placebo administered once daily p.o. for 12 weeks

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03905811

First Posted

April 1, 2019

Last Updated

May 12, 2022

Sponsor

Jordan Schultz

Collaborators

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT03905811

Brief Title

A Pilot Study of Terazosin for Parkinson's Disease

Acronym

TZ-PD

Official Title

A Pilot Study of Terazosin for Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 24, 2019 (Actual)

Primary Completion Date

June 5, 2020 (Actual)

Study Completion Date

November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jordan Schultz

Collaborators

University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

terazosin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

Terazosin administered 5 mg once daily p.o. for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered once daily p.o. for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Terazosin 5 MG

Other Intervention Name(s)

Hytrin

Intervention Description

5 milligrams by mouth daily at bedtime

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Other Intervention Name(s)

Placebo

Intervention Description

1 capsule by mouth daily at bedtime

Primary Outcome Measure Information:

Title

Incidence of Intervention-related Adverse Events Between Treatment Arms

Description

All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.

Time Frame

12 weeks

Title

Incidence of Falls Between Treatment Arms

Description

The number of participants in each group who report a fall, as determined by the site investigator, will be reported.

Time Frame

12 weeks

Title

Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason

Description

The number of participants in each group who drop out of the study for any reason will be compared.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

To Assess the Mean Change in Blood Pressure

Description

Time Frame

At Baseline, 2 weeks, 6 weeks, and 12 weeks

Title

Number of Participants With Intolerable Side Effects

Description

How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.

Time Frame

12 weeks

Title

Participants Demonstrating Non-Compliance

Description

Time Frame

At 2 weeks, 6 weeks and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jordan Schultz, PharmD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nandakumar Narayanan, MD, PhD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

A Pilot Study of Terazosin for Parkinson's Disease

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