A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TO Pharmaceuticals

Criteria

Inclusion Criteria:

• Signed informed consent

• Children ages two to eight years old with a documented diagnosis of ASD.

• Children with a previous report of behavioral issues characterized by aggression, anxiety, restlessness, sleep disturbances and/or self-harm, all as a part of the ASD, as documented in previous clinical estimation and examination.

• Hebrew speaking and reading.

Exclusion Criteria:

• Children that are treated with cannabis, anti-psychotic drugs or stimulants.

• Children with a comorbidity of heart, liver, kidney or hematologic disease.

• Children that are treated with one of the following drugs: Astemizole, Cisapride, Pimozide or Terfenadine.

• Children that suffer from epilepsy

• Children which themselves or a first-degree family member suffer from psychosis and/or another mental illness.

• Children in any condition in which the investigator is of the opinion that participating in the study is not the best option for them.

• Children who underwent surgery during the 30 days prior to the trial.

• Children that are participating in another trial which includes any intervention.