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

NCT05413187 | Withdrawn Phase 2

• 1 other identifier: SCRC17039
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autistic Disorder

Keywords

Cannabis; Autism

Outcome Measures

Primary Outcomes (1)

• change in symptoms of Autism spectrum disorder

  Superiority in reducing symptoms of Autism spectrum disorder as described and quantified via parent questionnaires and clinical assessment held by a specialized physician, in five main categories - sensory behavior, social relating, body and object use, language and communication skills, and social and adaptive skills. Clinical estimation will be held via the Aberrant Behavior Checklist-Community (ABC-C) questionnaire. Clinical estimation will be performed at the beginning and the end of each phase. Comparison will be held between clinical estimation results after treatment with MCG versus after treatment with placebo for both arms.

  32 weeks

Secondary Outcomes (4)

• change in score of The Clinical Global Impressions-Improvement (CGI-I)

  32 weeks

• change in score of Sensory Profile II (SP-2)

  32 weeks

• Changes in eye movements

  32 weeks

• Changes in the sleep architecture (optional)

  32 weeks

Study Arms (2)

Medical Grade Cannabis oil 30% CBD ,1.5% Δ9-THC

ACTIVE COMPARATOR

during phase 1; subjects will receive cannabis oil. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase.

Drug: Medical Grade Cannabis oil

Olive oil and Chlorophyl

PLACEBO COMPARATOR

during phase 1; subjects will receive placebo. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase.

Drug: Placebos

Interventions

Medical Grade Cannabis oil DRUG

MGC, 30% CBD and 1.5% Δ9-THC

Also known as: Cannabis oil

Medical Grade Cannabis oil 30% CBD ,1.5% Δ9-THC

Placebos DRUG

Olive oil and Chlorophyl

Olive oil and Chlorophyl

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TO Pharmaceuticals: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, 8410101, Israel

Location

MeSH Terms

Conditions

Autistic Disorder; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Lihi Bar-LEv

  Clinical team manager

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: During the trial procedures, SCRC coordinators and the sponsors will be exposed to the trial randomization. All other personnel including principle investigator, investigators, research assistants etc. will be blinded to the randomization and trial arms.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately forty children between the ages of two to eight years old with a documented diagnosis of Autism. The trial population will be randomized in a 1:1 ratio.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: June 9, 2022
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)