Open-Label Extension Study of Trofinetide for Rett Syndrome

Exclusion Criteria

• •1. Began treatment with growth hormone during the antecedent study
• •2. Began treatment with IGF-1 during the antecedent study
• •3. Began treatment with insulin during the antecedent study
• •4. Has developed a clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease)
• •5. 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
• •6. Has a clinically significant abnormality in vital signs at Baseline
• •7. Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of trofinetide is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
• •8. Has developed a clinically significant ECG finding during the antecedent study