Study of ANAVEX2-73 in Patients With Rett Syndrome

Exclusion Criteria

• •Patients who have a progressive medical or neurological condition that in the opinion of the Investigator would interfere with the conduct of the study.
• •Current clinically significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
• •History of clinically evident stroke or clinically significant carotid or vertebrobasilar stenosis or plaque or other history of neurologic (e.g., head trauma with loss of consciousness) or psychiatric condition that the Investigator deems may interfere with interpretability of data.
• •Indication of liver disease, defined by serum levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal (ULN) as determined during screening.
• •Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years.
• •Other clinically significant abnormality on physical, neurological, laboratory, or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that could compromise the study or be detrimental to the participant.
• •Any known hypersensitivity to any of the excipients contained in the study drug or placebo formulation.
• •Other co-morbid or chronic illness beyond that known to be associated with RTT.
• •Subjects who plan to initiate or change pharmacologic or nonpharmacologic intervention during the course of the study.
• •Subjects on potent CYP 3A4 and CYP2C19 inhibitors and inducers.
• •Subjects taking another investigational drug currently or within the last 30 days.
• •Any other criteria (such as a clinically significant screening blood test result), which in the opinion of the Investigator could interfere with the study conduct or outcome.
• •Patients with hepatic and renal impairment.