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A Double Blind, Placebo Controlled, Fixed-Flexible Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT05657860-Jul 28, 2026
NCT ID
NCT05657860
Status
COMPLETED
Phase
Phase 4
Sponsor
Maimonides Medical Center
Executive brief
Investment-Ready Snapshot
Guanfacine Extended Release (GXR) is being evaluated for its efficacy in reducing aggression and self-injurious behavior in individuals with Prader-Willi Syndrome (PWS). This clinical trial, sponsored by Maimonides Medical Center, addresses a significant unmet need in the management of behavioral symptoms associated with PWS, a genetic disorder affecting appetite and behavior. If successful, GXR could capture a niche market within the pediatric and adolescent populations suffering from PWS, potentially expanding its use beyond its current FDA-approved indications for hypertension and ADHD. The competitive landscape includes other behavioral interventions and pharmacotherapies, but GXR's specific targeting of aggression and self-injury in PWS may provide a unique selling proposition. Diligence should focus on the trial's safety profile and metabolic effects, as these will be critical for market acceptance and physician adoption.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT05657860
Indication
Prader-Willi Syndrome
Modality
small molecule
Target
Adrenergic alpha-2 Receptor Agonist
Intervention
Guanfacine Extended Release, Placebo
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.