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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: Completed Phase 4 study of Parkinson Disease and REM Sleep Behavior Disorder, sponsored by Stanford University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Sodium Oxybate
Study Locations (1)
California
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-09-10 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 4 |
What the finished NCT04006925 record still lists
NCT04006925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT04006925's enrollment target sits among peer trials
24 232nd of 297 higher than 61 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease 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.
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