Status:
ACTIVE_NOT_RECRUITING
CASCADE: CAnnabidiol Study in Children With Autism Spectrum DisordEr
Lead Sponsor:
University of Colorado, Denver
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
This is a randomized, placebo-controlled study but all study participants will receive the active study medication at some point during the study for at least 12 weeks, and some children with receive ...
Detailed Description
Autism spectrum disorder (ASD) is a relatively common neurodevelopmental disorder manifest by social communication deficits and restricted and repetitive interests. Individuals with ASD often have beh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04520685
Start Date
December 15 2021
End Date
December 31 2024
Last Update
May 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045