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An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001) — PWS-001  

Prader-Willi Syndrome Clinical Trial

Official title:
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)

Clinical Trial Summary

A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Prader-Willi Syndrome.

Clinical Trial Description

The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with NNZ-2591 oral solution in children and adolescents with Prader-Willi Syndrome. The secondary purpose is to investigate measures of efficacy. Subjects will receive treatment with NNZ-2591 oral solution (50 mg/mL) doses for a total of 13 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05879614
Study type Interventional
Source Neuren Pharmaceuticals Limited
Contact
Status Suspended
Phase Phase 2
Start date September 1, 2023
Completion date June 30, 2024
View Details
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