Terazosin for Parkinson's Disease (TZ-PD)
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|ClinicalTrials.gov Identifier: NCT03905811|
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2019
Last Update Posted : January 30, 2020
|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)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 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
- 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.
- To assess the mean change in systolic and diastolic blood pressures [ Time Frame: At 2 weeks, 6 weeks and 12 weeks ]
- 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.
- Mean change in systolic and diastolic blood pressure [ Time Frame: From baseline to 2 weeks to 6 weeks and 12 weeks ]
- Prevalence of falls between placebo and active group [ Time Frame: 12 weeks ]
- Prevalence of intolerable side effects between placebo and active group [ Time Frame: 12 weeks ]
- Prevalence of study discontinuation between placebo and active group [ Time Frame: 12 weeks ]
- Differences in overall compliance between placebo and active group as assessed by pill counts [ 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.
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|