OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Exclusion Criteria

• •History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary.
• •Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
• •History of suicide attempt or inpatient psychiatric hospitalization
• •Has a clinically significant abnormality in vital signs at Baseline
• •Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
• •Has developed a clinically significant ECG finding during the antecedent study
• •Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study