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Clinical Trial Summary

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


Study Design


Related Conditions & MeSH terms


NCT number NCT05025241
Study type Interventional
Source Neuren Pharmaceuticals Limited
Contact James Shaw
Phone +61 427 299 669
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2021
Completion date September 30, 2022

See also
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Recruiting NCT02461420 - Mapping the Genotype, Phenotype, and Natural History of Phelan-McDermid Syndrome
Completed NCT02000167 - Mitochondrial Dysfunction in Phelan-McDermid Syndrome
Enrolling by invitation NCT04312152 - Q10 Ubiquinol in Autism Spectrum Disorder and in Phelan-McDermid Syndrome. N/A
Recruiting NCT01525901 - Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) Phase 2
Completed NCT02710084 - Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome Phase 2