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NCT03848481 · ClinicalTrials.gov registry record · Phase 2
CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)
A Phase 2 study of Prader-Willi Syndrome, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03848481: Completed Phase 2 study of Prader-Willi Syndrome, sponsored by Montefiore Medical Center.
NCT03848481 is a Phase 2 study of Prader-Willi Syndrome that has completed, run by Montefiore Medical Center. The registered enrollment target is 14 participants, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03848481, a Phase 2 study of Prader-Willi Syndrome, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.
Primary Outcome
Irritability will be assessed using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I). The ABC-I is a well-characterized outcome that is accepted by the FDA for the purpose of labeling and is one of the best and most validated outcome measures in the developmental disabilities. The ABC-Irritability subscale consists of 15 questions that address the presence of irritability, aggression, tantrums and/or self-injury. Each item is rated on a scale ranging from 0 ("Not at all a problem")
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CBDV Compound
Study Locations (1)
New York
- Montefiore Medical Center, Albert Einstein College of Medicine - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 2 |
What the finished NCT03848481 record still lists
NCT03848481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 70-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03848481 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03848481 about?
NCT03848481 is a clinical study titled "CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)". This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.
What is the current status of trial NCT03848481?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-11-23. Estimated completion is 2024-10-31.
What conditions does trial NCT03848481 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome.
What interventions are being tested in trial NCT03848481?
The interventions under investigation include: Placebo (DRUG), CBDV Compound (DRUG).
Who is sponsoring clinical trial NCT03848481?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03848481 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prader-Willi Syndrome
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 NCT03848481's enrollment target sits among peer trials
14 14th of 16 higher than 3 of 16 other Prader-Willi Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prader-Willi Syndrome 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
-
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