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Trial record 5 of 48 for:    iowa | parkinsons

Terazosin for Parkinson's Disease (TZ-PD)

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ClinicalTrials.gov Identifier: NCT03905811
Recruitment Status : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
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)
Estimated Enrollment : 20 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
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 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

Placebo Comparator: Placebo
Placebo administered once daily p.o. for 12 weeks
Drug: Placebo oral capsule
1 capsule by mouth daily at bedtime




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. To assess the mean change in systolic and diastolic blood pressures [ Time Frame: At 6 weeks and 12 weeks ]
  4. 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. Mean change in systolic and diastolic blood pressure [ Time Frame: From baseline to 6 weeks and 12 weeks ]
  2. Prevalence of falls between placebo and active group [ Time Frame: 12 weeks ]
  3. Prevalence of intolerable side effects between placebo and active group [ Time Frame: 12 weeks ]
  4. Prevalence of study discontinuation between placebo and active group [ Time Frame: 12 weeks ]
  5. Differences in overall compliance between placebo and active group as assessed by pill counts [ Time Frame: At 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.



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
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.
  • 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).
  • 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

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Responsible Party: Jordan Schultz, PharmD, University of Iowa
ClinicalTrials.gov Identifier: NCT03905811     History of Changes
Other Study ID Numbers: 201902772
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
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:
terazosin
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
Prazosin
Terazosin
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
Antihypertensive Agents