Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Autism
• Age: Between 5 years - 18 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects with diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5criteria.
  2. Subject with a score of 18 or great on the Irritability Subscale on the Aberrant Behavior Checklist (ABC).
  3. Subjects with a score of 66T on the Social Responsiveness Scale (SRS)
  4. Subjects who will have a stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to randomization and for the duration of the study
  5. Physical exam and laboratory results that are within normal range for individuals with ASD
  6. Presence of a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the child’s development and behavior throughout the study.
  7. Subjects able to provide appropriate consent and assent

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects exposed to any investigational agent in the 30 days prior to randomization
  2. Subjects with prior chronic treatment with CBD, CBDV or an endocannabinoid treatment.
  3. Positive testing for THC or other drugs of abuse via urine testing at the screening visit or baseline visits upon repeat confirmation testing
  4. Recent history of drug abuse including marijuana/cannabis use in the past 3 months
  5. Subjects with diagnosis of a known genetic disorder
  6. Subjects who have a primary psychiatric diagnosis other than ASD
  7. A medical condition that severely impacts the subject’s ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results or endangers the subject’s well-being
  8. Subjects with a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder
  9. Subjects who have had changes in allied health therapies
  10. Subjects who have had changes in medications or medication doses within four weeks of randomization.
  11. Subjects with liver dysfunction
  12. Subjects with ECG abnormality
  13. Subjects who are pregnant
  14. Subjects with known allergy to sesame oil