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NCT04386317 · ClinicalTrials.gov registry record · Phase 2
Terazosin Effect on Cardiac Changes in Early Parkinson's Disease
A Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, sponsored by Cedars-Sinai Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04386317: Active Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, sponsored by Cedars-Sinai Medical Center.
NCT04386317 is a Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease that is active but no longer recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 15 participants, below the 156-participant average among 11 other REM Sleep Behavior Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04386317, a Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, is active but no longer recruiting, sponsored by Cedars-Sinai Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Parkinson's disease (PD) is characterized by many non-motor symptoms that occur several years before the diagnosis, in particular idiopathic REM behavior disorder (iRBD), which is associated with autonomic impairment. The purpose of this study is to investigate the effect of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on 123I-MIBG myocardial uptake in a population of subjects with defined pre-motor PD risks (i.e. hyposmia and RBD) and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms. Scintigraphic changes will be correlated to motor and non-motor severity of PD, measured by validated clinical scales and cardiac autonomic function tests.
Primary Outcome
1\) Differences in 123I-MIBG reuptake, as measured by early and late H/M ratio, and WR, at 26 weeks of treatment with the adrenergic blocker Terazosin.
Conditions Studied
Interventions
- DRUG Terazosin
Study Locations (1)
California
- Michele L Lima Gregorio - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2026-03-10 |
| Phase | Phase 2 |
What the registry record for NCT04386317 still lists
NCT04386317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 156-participant average among 11 other REM Sleep Behavior Disorder trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with REM Sleep Behavior Disorder appearing as the primary indexed condition, and to 1 intervention - of which Terazosin is the first listed.
NCT04386317 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04386317 about?
NCT04386317 is a clinical study titled "Terazosin Effect on Cardiac Changes in Early Parkinson's Disease". Parkinson's disease (PD) is characterized by many non-motor symptoms that occur several years before the diagnosis, in particular idiopathic REM behavior disorder (iRBD), which is associated with autonomic impairment. The purpose of this study is to investigate the effect of treatment with the selec...
What is the current status of trial NCT04386317?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2020-11-01. Estimated completion is 2026-03-10.
What conditions does trial NCT04386317 study?
This clinical trial studies the following conditions: REM Sleep Behavior Disorder, Symptomatic Parkinson Disease, Pre-motor Parkinson's Disease.
What interventions are being tested in trial NCT04386317?
The interventions under investigation include: Terazosin (DRUG).
Who is sponsoring clinical trial NCT04386317?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04386317 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for REM Sleep Behavior Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04386317's enrollment target sits among peer trials
15 9th of 11 the lowest of 11 other REM Sleep Behavior Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other REM Sleep Behavior Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Cardiac Changes in Early Parkinson's Disease: A Follow up Study
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-
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-
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-
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
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-
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RECRUITING · NA
-
Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
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