To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Males or females aged between 5 and 18 years of age (inclusive)
Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
Presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study
Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
Children with heart, liver, renal or hematological disorders.
History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study
Exposure to any investigational agent in the 30 days prior to trial onset.
Neurothera Labs Inc.
Lead sponsor
Negev Autism Center Soroka University Medical Center
Collaborator