A Pilot Study of Terazosin for Parkinson's Disease

NCT03905811 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 201902772
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

terazosin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• To Assess the Mean Change in Blood Pressure

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

• Number of Participants With Intolerable Side Effects

  12 weeks

• Participants Demonstrating Non-Compliance

  At 2 weeks, 6 weeks and 12 weeks

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: Terazosin 5 MG

Placebo

PLACEBO COMPARATOR

Placebo administered once daily p.o. for 12 weeks

Drug: Placebo oral capsule

Interventions

Terazosin 5 MG DRUG

5 milligrams by mouth daily at bedtime

Also known as: Hytrin

Active

Placebo oral capsule DRUG

1 capsule by mouth daily at bedtime

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Schultz: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Terazosin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

-Recruitment halted early due to the onset of the COVID-19 Pandemic.

Results Point of Contact

• Title: Jordan Schultz
• Organization: University of Iowa

jordan-schultz@uiowa.edu

3193849388

Study Officials

• Jordan Schultz, PharmD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Nandakumar Narayanan, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 5, 2019
• Study Start: September 24, 2019
• Primary Completion: June 5, 2020
• Study Completion: November 18, 2020
• Last Updated: May 16, 2022
• Results First Posted: August 2, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)