A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

Exclusion Criteria

• •1. Use of exclusionary medication or unstable treatment regimens of acceptable concomitant medications as required by the protocol.
• •2. Current treatment with more than 3 allowable psychotropic medications.
• •3. Participants with seizures must be controlled on no more than 2 anticonvulsant medications (not counting rescue medications).
• •4. Psychotropic medications or any other medication used for a chronic illness (not including antibiotics, pain relievers, anti-diarrheals, and laxatives) with doses and dosing regimen that have not been stable for at least 4 weeks before Screening. If the treatment was discontinued, the discontinuation must have occurred no fewer than 2 weeks before the start of Screening.
• •5. Any intercurrent seizures in the past 6 months and /or more than 1 seizure in the past 12 months. •A single febrile seizure in the 6 months prior to screening is allowable if no rescue medication was required.
• •6. Abnormal liver function laboratory results during the Screening period, as defined by the protocol
• •7. Abnormal QT interval on Screening ECG as defined by the protocol.