A Pilot Study of Terazosin for Parkinson's Disease (TZ-PD)
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|ClinicalTrials.gov Identifier: NCT03905811|
Recruitment Status : Completed
First Posted : April 5, 2019
Results First Posted : August 2, 2021
Last Update Posted : May 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Terazosin 5 MG Drug: Placebo oral capsule||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Pilot Study of Terazosin for Parkinson's Disease|
|Actual Study Start Date :||September 24, 2019|
|Actual Primary Completion Date :||June 5, 2020|
|Actual Study Completion Date :||November 18, 2020|
Terazosin administered 5 mg once daily p.o. for 12 weeks
Drug: Terazosin 5 MG
5 milligrams by mouth daily at bedtime
Other Name: Hytrin
Placebo Comparator: Placebo
Placebo administered once daily p.o. for 12 weeks
Drug: Placebo oral capsule
1 capsule by mouth daily at bedtime
Other Name: Placebo
- 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.
- 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.
- 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.
- To Assess the Mean Change in Blood Pressure [ Time Frame: At Baseline, 2 weeks, 6 weeks, and 12 weeks ]Mean change in sitting systolic blood pressure and diastolic blood pressure from baseline reading at 2 weeks, 6 weeks, and 12 weeks. A negative number indicates a decrease in blood pressure while a positive number indicates an increase in blood pressure.
- Number of Participants With Intolerable Side Effects [ Time Frame: 12 weeks ]How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.
- Participants Demonstrating Non-Compliance [ Time Frame: At 2 weeks, 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. A participant will be considered non-compliant if they had more than 5 missed doses during the course of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905811
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Jordan Schultz, PharmD||University of Iowa|
|Principal Investigator:||Nandakumar Narayanan, MD, PhD||University of Iowa|