A Pilot Study of Terazosin for Parkinson's Disease

NCT ID: NCT03905811

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2020-11-18

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

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

Group Type: EXPERIMENTAL

Terazosin 5 MG

Intervention Type: DRUG

5 milligrams by mouth daily at bedtime

Placebo

Placebo administered once daily p.o. for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

1 capsule by mouth daily at bedtime

Interventions

Terazosin 5 MG

5 milligrams by mouth daily at bedtime

Intervention Type: DRUG

Placebo oral capsule

1 capsule by mouth daily at bedtime

Intervention Type: DRUG

Other Intervention Names

Hytrin; Placebo

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

Jordan Schultz

OTHER

Sponsor Role: lead

Responsible Party

Jordan Schultz

PharmD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jordan Schultz, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Nandakumar Narayanan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201902772

Identifier Type: -

Identifier Source: org_study_id