To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Males or females aged between 5 and 18 years of age (inclusive)
Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
Presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study
Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
Children with heart, liver, renal or hematological disorders.
History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study
Exposure to any investigational agent in the 30 days prior to trial onset.
Crossover
SCI-210
DrugOral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily
Oral CBD oil
DrugCBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in CGI-I scores during the different periods of the study between the two treatment and control groups.
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in ABC-C scores during the different periods of the study between the two treatment and control groups.
Evaluate the safety of SCI-210 in children with ASD.
Evaluate the safety of SCI-210 in children with ASD throughout the 24 week treatment periodAdverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Evaluate the tolerability of SCI-210 in children with ASD.
Evaluate the tolerability of SCI-210 in children with ASD throughout the 24 week treatment period Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD
Parents will fill out the following questionnaire at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage: The Social Responsiveness Scale (SRS) will be used to estimate changes in the social abilities of the child. A total composite score between 60 and 65 is associated with mild to moderate deficits in social interaction. Scores between 66 and 75 are considered to display a moderate deficit in social interaction, and a score greater than 76 is considered severe and strongly associated with the clinical diagnosis of ASD
Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD
Parents will fill out the following questionnaire at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage: The Children's Sleep Habit Questionnaire (CSHQ) will be used to estimate changes in the sleep quality of the child. A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A Total Sleep Disturbances score of over 41 indicates a pediatric sleep disorde.
Click on the lead sponsor to view all of their trials.
Neurothera Labs Inc.
Lead sponsor
Negev Autism Center Soroka University Medical Center
Collaborator
