Phase 2
Completed N=13
A Pilot Study of Terazosin for Parkinson's Disease
Source: ClinicalTrials.gov NCT03905811 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Incidence of Intervention-related Adverse Events Between Treatment Arms — 11; 4 Event
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Intervention-related Adverse Events Between Treatment Arms |
11; 4 | — |
| PRIMARY Incidence of Falls Between Treatment Arms |
0; 0 | — |
| PRIMARY Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason |
3; 0 | — |
| SECONDARY To Assess the Mean Change in Blood Pressure |
-5.29; -2.20; -15.05; 2.20; -11.0; -3.20 | — |
| SECONDARY Number of Participants With Intolerable Side Effects |
3; 0 | — |
| SECONDARY Participants Demonstrating Non-Compliance |
0; 0; 0; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT03905811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.