Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary: This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).


Options:
A: Inclusion criteria:

* A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified (PDD-NOS), given by a child neurologist.
* Age: 10-18 years.
* A signed parental consent form.

Exclusion criteria:

* Evidence for one of the following conditions:

  * an underlying infectious disease
  * chromosomal abnormality
  * metabolic disorder
  * specific brain related disorder (such as tuberous sclerosis)
  * history of fetal cytomegalovirus infection
  * birth asphyxia
  * a history of major head injury
  * a chronic use of non-steroidal anti-inflammatory drugs, (NSAID)
  * known brain damage
* Epilepsy
* Abnormal Electro-cardiogram (ECG)
* Epileptiform EEG
* Use of psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents within the past month.
* Lack of cooperation in the screening phase
B: Inclusion Criteria:

* Diagnosis of autism

Exclusion Criteria:

* Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or Pervasive Development Disorder-Not Otherwise Specified
* Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is medically inadvisable
* Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or melatonin for sleep)
* Recent use of stimulants within 5 days prior to enrollment
* Ongoing need for or recent use of most psychotropic medications within 14 days of enrollment
* Recent initiation of specialized educational, behavioral, or diet intervention for autism in the month prior to enrollment
C: Inclusion Criteria:

1. Outpatients 5-17 years of age inclusive.
2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). DSM-5 criteria will be established by a clinician with expertise with individuals with ASD. Diagnosis will be supported by the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
3. Complex language to qualify for ADOS-2 modules 3 or 4.
4. If already receiving stable concomitant medications affecting behaviour, have stable regimens with no changes during the preceding 6 weeks prior to Screening, and will not electively initiate new or modify ongoing medications for the duration of the study.
5. If already receiving stable non-pharmacological educational and behavioural interventions, have continuous participation during the preceding 3 months prior to Screening, and will not electively initiate new or modify ongoing interventions for the duration of the study.
6. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
7. Ability to obtain written informed consent from the participant, if developmentally appropriate. If a participant does not have the capacity to consent, ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian(s).

Exclusion Criteria:

1. Pregnant females; sexually active females on inadequate birth control.
2. Have a serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Have evidence of any significant hematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common pediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.).
3. Have unstable epilepsy (i.e. seizures occurring within the last 6 months), or have epilepsy and not on stable doses of antiepileptic medications (i.e. dose changes within the last 3 months).
4. Have a history of drug abuse.
5. Have hypersensitivity to arbaclofen or any components of its formulation.
6. Unable to tolerate venipuncture procedures for blood sampling.
7. Actively enrolled in another intervention study.
8. Taking racemic bacblofen, vigabatrin, tiagapine, riluzole, clobazam or regular benzodiazepine use (prn and hs use is allowed).
9. Unable to take oral medications.
10. Known hypersensitivity to racemic baclofen.
11. Inability to speak and understand English sufficiently enough to allow for the completion of all study assessments (parent/legal guardian; participant).
D: Inclusion Criteria:

* Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
* Subject between the ages of 24-72 months of age.
* A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
* Stable medications during the two months prior to enrollment.
* Currently receiving interventions in the community or school for Autism Spectrum Disorder

Exclusion Criteria:

* Current or past Selective Serotonin Reuptake Inhibitor treatment.
* Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.

Answer: C