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NCT05657860 · ClinicalTrials.gov registry record · Phase 4
Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
A Phase 4 study, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT05657860: Completed Phase 4 study, sponsored by Maimonides Medical Center.
NCT05657860 is a Phase 4 study that has completed, run by Maimonides Medical Center. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05657860, a Phase 4 study, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS). In addition, the study will establish the safety of GXR with a specific focus on metabolic effects.
Primary Outcome
Clinical Global Impression-Improvement is a 7 item scale. A rating of 0=not assessed, 1= very much improved, 2= much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6= much worse, and 7= very much worse. Scores after "4" indicate a decreasing health outcome. Positive clinical response will be determined by a rating of 1= very much improved or 2= Much improved at the end of the blinded trial.
Interventions
- OTHER Placebo
- DRUG Guanfacine Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2023-12-16 |
| Phase | Phase 4 |
What the finished NCT05657860 record still lists
NCT05657860 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05657860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05657860 about?
NCT05657860 is a clinical study titled "Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome". This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS). In addition, the study will establish the safety of GXR with a specific focus on metabolic effects.
What is the current status of trial NCT05657860?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2020-12-17. Estimated completion is 2023-12-16.
What interventions are being tested in trial NCT05657860?
The interventions under investigation include: Placebo (OTHER), Guanfacine Extended Release (DRUG).
Who is sponsoring clinical trial NCT05657860?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05657860's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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