Clinical trial NCT03905811: A Pilot Study of Terazosin for Parkinson's Disease
Official title: A Pilot Study of Terazosin for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Keywords: terazosin
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2019-04-05
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Intervention-related Adverse Events Between Treatment Arms
timeFrame: 12 weeks
measure: Incidence of Falls Between Treatment Arms
timeFrame: 12 weeks
measure: Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason
timeFrame: 12 weeks
Secondary outcomes:
measure: To Assess the Mean Change in Blood Pressure
timeFrame: At Baseline, 2 weeks, 6 weeks, and 12 weeks
measure: Number of Participants With Intolerable Side Effects
timeFrame: 12 weeks
measure: Participants Demonstrating Non-Compliance
timeFrame: At 2 weeks, 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jordan Schultz, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Nandakumar Narayanan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: