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NCT04006925 · ClinicalTrials.gov registry record · Phase 4

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

A Phase 4 study of Parkinson Disease and REM Sleep Behavior Disorder, sponsored by Stanford University.

Completed
Registry status
Phase 4
Development phase
24
Enrollment target
1
Study location

NCT04006925 is a Phase 4 study of Parkinson Disease and REM Sleep Behavior Disorder that has completed, run by Stanford University. The registered enrollment target is 24 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04006925, a Phase 4 study of Parkinson Disease and REM Sleep Behavior Disorder, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 4
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal, 2016; Moghadam, 2017).

Conditions Studied

Parkinson Disease REM Sleep Behavior Disorder

Interventions

  • OTHER Placebo
  • DRUG Sodium Oxybate

Study Locations (1)

California

  • Stanford University - Palo Alto

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2019-09-10
Est. Completion 2022-02-01
Phase Phase 4

Sponsor

Stanford University

1,744 total trials

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What the Registry Record Tells You About NCT04006925

The ClinicalTrials.gov registry entry for NCT04006925 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04006925 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04006925 about?

NCT04006925 is a clinical study titled "Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate". This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well...

What is the current status of trial NCT04006925?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2019-09-10. Estimated completion is 2022-02-01.

What conditions does trial NCT04006925 study?

This clinical trial studies the following conditions: Parkinson Disease, REM Sleep Behavior Disorder.

What interventions are being tested in trial NCT04006925?

The interventions under investigation include: Placebo (OTHER), Sodium Oxybate (DRUG).

Who is sponsoring clinical trial NCT04006925?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04006925 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.