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Clinical Trials

ConSynance is committed to advancing clinical research for Prader-Willi syndrome and related rare CNS disorders. Our current studies evaluate CSTI-500, an investigational oral therapy designed to address behavioral dysregulation and hyperphagia.

NCT07348601

 
Phase 2 CSTI-500 in Prader-Willi Syndrome

RECRUITING

Investigational oral therapy evaluating safety, tolerability, pharmacokinetics, and potential effects on behavioral dysregulation and hyperphagia​ in PWS. Potential participants may include individuals aged 13–50 years with genetically confirmed Prader-Willi syndrome who meet study eligibility requirements.

Interested in participating in this study?

For questions about participation or study eligibility, please contact:
Elizabeth Roof
Vanderbilt University Medical Center
elizabeth.roof@vanderbilt.edu

615-343-3330

Phase: Phase 2
Design: Open-label

Status: Recruiting
Age Range: 13-50 years

Genetic subtype: Chromosome 15 deletion

Location: Vanderbilt University Medical Center

Sponsor: ConSynance Therapeutics, Inc.

CSTI-500 is an investigational therapy and has not been approved by the FDA or other regulatory authorities. Participation in clinical research is voluntary and eligibility criteria apply.

NCT05504395

 
Phase 1 CSTI-500 Pharmacokinetic and Safety Study in Prader-Willi Syndrome

COMPLETED

This Phase 1 clinical study evaluated the pharmacokinetics and safety of a single oral dose of CSTI-500 in individuals with genetically confirmed Prader-Willi syndrome. The study was conducted at Vanderbilt University Medical Center and supported advancement of CSTI-500 into Phase 2 development.

Phase: Phase 1
Design: Open-label, single-center, single-dose

Status: Completed
Age Range: 13-50 years

Location: Vanderbilt University Medical Centre

Sponsor: ConSynance Therapeutics, Inc.

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