A Phase 1/2 interventional study of Terazosin 5 MG and Placebo oral capsule in Parkinson Disease, sponsored by Jordan Schultz. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-05-16.
Sponsored by Jordan Schultz · Phase 1/2, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Jordan Schultz is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Terazosin administered 5 mg once daily p.o. for 12 weeks
Drug: Terazosin 5 MG
Placebo administered once daily p.o. for 12 weeks
Drug: Placebo oral capsule
5 milligrams by mouth daily at bedtime
Also known as: Hytrin
1 capsule by mouth daily at bedtime
Also known as: Placebo
Incidence of Intervention-related Adverse Events Between Treatment Arms
All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.
Time frame: 12 weeks
Incidence of Falls Between Treatment Arms
The number of participants in each group who report a fall, as determined by the site investigator, will be reported.
Time frame: 12 weeks
Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason
The number of participants in each group who drop out of the study for any reason will be compared.
Time frame: 12 weeks
To Assess the Mean Change in Blood Pressure
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.
Time frame: At Baseline, 2 weeks, 6 weeks, and 12 weeks
Number of Participants With Intolerable Side Effects
How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.
Time frame: 12 weeks
Participants Demonstrating Non-Compliance
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.
Time frame: At 2 weeks, 6 weeks and 12 weeks
| Milestone | Active | Placebo |
|---|---|---|
| Started | 8 | 5 |
| Completed | 6 | 5 |
| Not completed | 2 | 0 |
All patient-reported adverse events will be determine to be related to the study intervention by the site investigator.
| Event | Active | Placebo |
|---|---|---|
| Incidence of Intervention-related Adverse Events Between Treatment Arms | 11 | 4 |
The number of participants in each group who report a fall, as determined by the site investigator, will be reported.
| Event | Active | Placebo |
|---|---|---|
| Incidence of Falls Between Treatment Arms | 0 | 0 |
The number of participants in each group who drop out of the study for any reason will be compared.
| Participants | Active | Placebo |
|---|---|---|
| Frequency of Drop-out From Study/Discontinuation of Study Intervention for Any Reason | 3 | 0 |
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.
| mmHg | Active | Placebo |
|---|---|---|
| Systolic at 2 weeks | -5.29 ± 12.6 | -2.20 ± 11.5 |
| Systolic at 6 weeks | -15.05 ± 8.21 | 2.20 ± 23.2 |
| Systolic at 12 weeks | -11.0 ± 16.1 | -3.20 ± 13.1 |
| Diastolic at 2 weeks | -2.00 ± 5.54 | -2.20 ± 8.87 |
| Diastolic at 6 weeks | -5.29 ± 4.54 | 4.20 ± 8.14 |
| Diastolic at 12 weeks | -9.40 ± 2.07 | -2.00 ± 11.3 |
How many participants discontinued study as a result of intolerable adverse events that were deemed to be medication-related.
| Participants | Active | Placebo |
|---|---|---|
| Number of Participants With Intolerable Side Effects | 3 | 0 |
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.
| Participants | Active | Placebo |
|---|---|---|
| Non-compliance at 2 weeks | 0 | 0 |
| Non-compliance at 6 weeks | 0 | 0 |
| Non-compliance at 12 weeks | 0 | 0 |
Collected over 12 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Placebo | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Event | Active | Placebo |
|---|---|---|
| Dizzy/LightheadednessNervous system disorders | 7/8 | 1/5 |
| UnsteadyNervous system disorders | 1/8 | 2/5 |
| Orthostatic HypotensionNervous system disorders | 2/8 | 0/5 |
| HeadacheNervous system disorders | 1/8 | 1/5 |
| FatigueNervous system disorders | 1/8 | 0/5 |
| Age, Continuous(years) | Active | Placebo | Total |
|---|---|---|---|
| Mean | 64.8 ± 6.1 | 68.8 ± 6.6 | 66.4 ± 6.3 |
| Sex: Female, Male(Participants) | Active | Placebo | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Active | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 5 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Jordan Schultz