Parkinson DiseasePhase 1/2TZ-PDNCT03905811
A Pilot Study of Terazosin for Parkinson's Disease
A Phase 1/2 study testing Terazosin 5 MG in people with Parkinson Disease, run by Jordan Schultz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Terazosin 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 18 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- Terazosin 5 MG, Placebo oral capsule
- Keywords
- terazosin
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terazosin 5 MGDrug
Also called Hytrin
5 milligrams by mouth daily at bedtime
Placebo oral capsuleDrug
Also called Placebo
1 capsule by mouth daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Terazosin administered 5 mg once daily p.o. for 12 weeks Receives: Drug: Terazosin 5 MG |
| Placebo | Placebo comparator | Placebo administered once daily p.o. for 12 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At 2 weeks, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start24 Sep 2019
- Primary completion5 Jun 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Schultz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Sponsor-investigator, Jordan Schultz, University of Iowa
- Investigators
- Jordan Schultz, PharmD, Principal investigator, University of IowaNandakumar Narayanan, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905811
- Sponsor's protocol ID
- 201902772
- Acronym
- TZ-PD
- Status last verified
- May 2022
- First submitted
- 1 Apr 2019
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Terazosin for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03905811
- Acronym / sponsor ID
- TZ-PD / 201902772
- Conditions
- Parkinson Disease
- Keywords
- terazosin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Jordan SchultzUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Posted 2 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Terazosin 5 MGTerazosin administered 5 mg once daily p.o. for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo administered once daily p.o. for 12 weeks |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terazosin 5 MGAlso: Hytrin5 milligrams by mouth daily at bedtime | Drug | Active |
| Placebo oral capsuleAlso: Placebo1 capsule by mouth daily at bedtime | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
To Assess the Mean Change in Blood Pressure
Time frame: At Baseline, 2 weeks, 6 weeks, and 12 weeks
Number of Participants With Intolerable Side Effects
Time frame: 12 weeks
Participants Demonstrating Non-Compliance
Time frame: At 2 weeks, 6 weeks and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Schultz, PharmD principal investigator
University of Iowa
Nandakumar Narayanan, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Terazosin 5 MG in people with Parkinson Disease, run by Jordan Schultz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intervention-related Adverse Events Between Treatment Arms (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.