A Follow-Up Shiftability Study of Arbaclofen with an Open-Label Extension for the study of Biomarkers for Treatment for Social Function in Children and Adolescents with Autism Spectrum Disorders

You may be able to join if

• 1) Signed Written Informed Consent a. Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care. Participants who do not have the capacity to consent will give developmentally appropriate assent. Participants who become adults (18 years of age) during the trial will sign a specific consent during the first visit when they are 18. b. Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing. c. The participant’s parent/caregiver/LAR must be able to speak and understand the local language where the study is conducted sufficiently to understand the nature of the study and to allow for the completion of all study assessments. The same parent/caregiver/LAR must be capable of providing reliable information about the participant’s condition, agree to oversee the administration of study drug, and accompany the participant to all clinic visits. d. Patient must be able to speak and understand the local language where the study is conducted sufficiently to understand the nature of the study and to allow for the completion of all study assessments.
• 2) Type of Participant and Target Disease Characteristics a. Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria b. Participarts are within the age-range: 5 to 23yo. c. Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study. d. Current psychotherapeutic/psychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the duration of the study (standard regular school breaks and/or annual teacher/classroom change do not qualify for intervention change). e. Participants with a history of seizure disorder must currently be receiving stable treatment with anticonvulsant medication and must have been seizure free for 6 months prior to screening or must be seizure free for 3 years prior to screening if not currently on a stable (>3 months) dose of antiepileptics.
• 3) Age, Residential and Reproductive Status a. Male or female participants 7 to 23 years of age at the time of providing consent, inclusive. b. Reside or regular contact (at least twice a week) with the parent/carer who is interviewed for the study. c. Negative pregnancy test for females of childbearing potential (participant has experienced onset of menses) d. Females of childbearing potential who are sexually active must agree to use a highly effective form of contraception (i.e., existing surgical sterilization, complete or abstinence or a combination of two affective forms of contraception, such as, for example, condoms plus hormonal treatment). Please, refer to Appendix 4 for a complete list of acceptable contraception methods. e. Male participants with female partners of childbearing potential are eligible to participate if they agree to the conditions stated in section 8.2.1.