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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2022 |
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Main ID: |
NCT03905811 |
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Date of registration:
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01/04/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Pilot Study of Terazosin for Parkinson's Disease
TZ-PD |
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Scientific title:
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A Pilot Study of Terazosin for Parkinson's Disease |
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Date of first enrolment:
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September 24, 2019 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03905811 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Nandakumar Narayanan, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Iowa |
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Name:
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Jordan Schultz, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Iowa |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Terazosin 5 MG
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Drug: Placebo oral capsule
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Primary Outcome(s)
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Incidence of Intervention-related Adverse Events Between Treatment Arms
[Time Frame: 12 weeks]
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Incidence of Falls Between Treatment Arms
[Time Frame: 12 weeks]
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Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Number of Participants With Intolerable Side Effects
[Time Frame: 12 weeks]
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Participants Demonstrating Non-Compliance
[Time Frame: At 2 weeks, 6 weeks and 12 weeks]
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To Assess the Mean Change in Blood Pressure
[Time Frame: At Baseline, 2 weeks, 6 weeks, and 12 weeks]
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Secondary ID(s)
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201902772
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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