CASCADE: CAnnabidiol Study in Children With Autism Spectrum DisordEr

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 17, 2020

Keywords

ClinConnect Summary

The CASCADE trial is exploring the effects of a medication called cannabidiol (CBD) on children and adolescents with Autism Spectrum Disorder (ASD). This study aims to see how well CBD can help improve symptoms related to ASD. It involves children aged 5 to 17 years who have been diagnosed with ASD and are experiencing moderate to severe challenges due to their condition. To participate, they should be in good health and on a stable medication plan if they are taking psychotropic drugs.

All participants in the study will receive the active medication for at least 12 weeks, although some may continue to receive it for the entire duration of the study. Families can expect regular visits and assessments throughout the trial to monitor their child's progress and well-being. It's important to note that this study is currently active but not recruiting new participants, and parents or caregivers will need to provide consent and support for their child’s participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female children and adolescents aged 5-17 years, inclusive, at the time of screening.
• • Judged by the investigator to be in good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results.
• • Patients must have a previous documented diagnosis of ASD by a medical or psychological professional.
• • Patients must be assessed by the Investigator as being moderately to severely impacted due to ASD
• • Patients who are taking psychotropic medication(s) should be on a stable regimen of no more than 2 medications for at least 4 weeks preceding study Screening and must maintain that regimen throughout the study. Psychotropic medications include (but are not limited to) antipsychotics, antidepressants, mood stabilizers, anxiolytics, and ADHD medications.
• • Patients with a history of seizure disorders must currently be receiving treatment with a stable regimen of one or two AEDs, or must be seizure-free for 1 year if not currently receiving AEDs.
• • Patients with seizures should be on a stable regimen for the 3 months preceding study enrollment of no more than 2 of the permitted anti-epileptic drugs (AEDs). Patients must remain on a stable AED dose throughout the study.
• • If patients are receiving non-pharmacological educational, behavioral, and/or dietary interventions or therapies, they must be stable and have been doing so for 2 months prior to screening. Changes with school breaks are expected and do not apply.
• • Patients must have a BMI of between 12-32 kg/m2 (inclusive).
• • Females of childbearing potential and must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at all designated visits.
• • Patients/caregivers agree to abide by all study restrictions and comply with all study procedures.
• • Parents/caregivers must be able to read and respond to questions and questionnaires in English.
• • Patients/caregivers must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
• • Parents/caregiver(s) must provide written consent to assist in study drug administration.
• • In the Investigator's opinion, patients/caregivers are reliable and willing and able to comply with all protocol requirements and procedures (including scheduled visits and confinement periods).
• Exclusion Criteria:
• • Adolescent females who are pregnant, nursing, or planning a pregnancy. Females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use standard acceptable methods of contraception (including abstinence, hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, or intrauterine device) for the duration of the study and for 1 month after the last dose of study medication.
• • History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to CBD (Epidiolex) or its ingredients.
• • Exposure to any investigational drug or device \< 30 days prior to screening, or plans to take another investigational drug at any time during the study.
• • Use of any THC or CBD-containing product within 4 weeks of Screening Visit, planned use during the study, or positive THC urine test at screening.
• • Patient is using the following medications: clobazam (Onfi, Frisium), felbamate (Felbatol), vigabatrin (Sabril), or everolimus (Afinitor).
• • Plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
• • Patient has ALT, AST, total bilirubin, or creatinine levels ≥ 2 times the ULN, alkaline phosphatase levels ≥ 3 times the ULN, or Hct \<1.2 times the LLN as determined from screening safety laboratories.
• • Severe or unstable symptoms of ASD that may interfere with the study outcome evaluations and interpretation of results.
• • Suffering from acute or progressive neurological disease, psychosis, schizophrenia or any psychiatric disorder or severe psychiatric abnormalities that are likely to require changes in drug therapy or interfere with the objectives of the study or the ability to adhere to protocol requirements.
• • Has suspected or confirmed cardiovascular disease.
• • History of treatment for, or evidence of, drug or alcohol abuse within the past year.