Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

Exclusion Criteria25

• Participant is judged by the Investigator to be unable to perform or comply with all study specific requirements.
• Participant is an employee of an investigator with direct involvement in the proposed study or other studies under the direction of a study investigator, or is a family member of an investigator.
• Participant has a history of any severe or unstable psychiatric condition (e.g., schizophrenia or other psychotic disorder, bipolar disorder, major depressive disorder) that, in the opinion of the Investigator, could confound the interpretation of the study results or put the participant at undue risk. An acute episode of a mood disorder will be considered exclusionary; a participant with a history of mild to moderate mood disorder may be included in the study under the discretion of the Investigator. Other stable psychiatric conditions are permitted at the discretion of the Investigator (e.g., attention deficit hyperactivity disorder, generalized anxiety disorder, etc.).
• Participant has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 3 or higher (active suicidal ideation with some intent to act, without specific plan) on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1.
• Participant has met DSM-5 criteria for a substance abuse disorder within the last 6 months prior to Screening, except for disorders related to caffeine or nicotine.
• Participant has a positive test for an illicit drug or cannabis at Screening or Baseline. Participants who test positive for cannabis and who have a valid prescription may be rescreened if they agree to abstain from the cannabis for the length of their participation in the study. The repeat test must be negative for them to participate in the study.
• Participant is taking a serotonin reuptake inhibitor or antipsychotic medication.
• Participant has had a change to psychotropic medications within the last 2 months
• Participant has received electroconvulsive therapy (ECT) in the last 6 months.
• Participant has received new-onset psychotherapy or has had a change in the intensity of psychotherapy within the 2 months prior to Screening.
• Participant has known allergies, hypersensitivity, or intolerance to Pimavanserin or its excipients.
• Participant has received an investigational drug or used an investigational medical device within 3 months before the planned start of study or is currently enrolled in an investigational study.
• Participant has a body mass index (BMI) \<17 or \>40 at Screening.
• Participant has a known history of long QT syndrome or family history of sudden death.
• Participant has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident (CVA) within the last 4 months. Has greater than NYHA Class 2 congestive heart failure or Class 2 angina pectoris, sustained ventricular tachycardia (VT), ventricular fibrillation, torsade de pointes, or syncope due to an arrhythmia.
• Participant has a history of neuroleptic malignant syndrome/serotonin syndrome.
• Participant has had a seizure within the past 12 months. Individuals with seizure disorders who are on stable seizure medications (i.e., without seizures in the past 12 months) are permitted at the discretion of the Investigator.
• Participant is pregnant or breast-feeding, or planning to become pregnant or breastfeed while enrolled in this study or within 3 months after the last dose of study drug.
• Participant has current evidence, or a history within the previous 3 months prior to screening, of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, that, in the opinion of the Investigator, would jeopardize the safe participation of the Participant in the study.
• Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence).
• Participant has a known history of a positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test.
• Participant has a Screening or Baseline ECG with a QTcF\>450ms when the QRS duration is \<120 ms or has a Screening or Baseline ECG with a QTcF\>470 ms when the QRS duration is \>120 ms.
• Participant has laboratory evidence of hypothyroidism at Screening, as measured by thyroid stimulating hormone (TSH) and reflex free thyroxine (T4). If TSH is abnormal and the reflex free T4 is normal, the Participant may be enrolled.
• Participant has current unstable diabetes or glycosylated hemoglobin (HbAIc) \>8% at Screening.
• Participant has other clinically significant laboratory abnormalities that, in the opinion of the Investigator, would jeopardize the safe participation of the study Participant.