Study of cannabidiol to reduce self-injurious behavior in children and adolescents with severe neurodevelopmental disorders

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What is this study about?

The study focuses on children and adolescents with severe neurodevelopmental disorders who exhibit self-injurious behavior. This condition involves repeated actions that can cause physical harm to oneself and significantly impacts daily activities, requiring constant supervision. The study aims to evaluate whether a medication called cannabidiol (Epidyolex) can help reduce the frequency of self-injuries in these young patients.

The medication being tested is Epidyolex, which comes as an oral solution that is taken by mouth. The treatment will be given to patients who have not responded well enough to previous treatments with medications called atypical neuroleptics (such as risperidone or aripiprazole). The study will last for 59 days, during which the medication will be given daily.

During the study, doctors will monitor how well the medication works in reducing self-injurious behaviors. They will also watch for any changes in other behaviors and check the overall well-being of the participants. The medication dose will be adjusted based on the patient’s weight, with a maximum daily dose of 40 mg per kilogram of body weight.

1 Initial visit (Day 0)

You will begin taking Epidyolex, an oral solution containing cannabidiol.

The medical team will evaluate your current condition and document your baseline symptoms.

2 Treatment period – First month

You will take Epidyolex oral solution daily.

The medical team will monitor your response to the treatment.

Your current medications and therapy sessions will continue unchanged.

3 Day 31 evaluation

The medical team will assess changes in your condition after the first month of treatment.

They will evaluate any improvements in self-injurious behaviors.

Your overall well-being and any side effects will be documented.

4 Continued treatment – Second month

Daily treatment with Epidyolex continues.

Regular monitoring of your condition will continue.

Any side effects should be noted and reported during check-ups.

5 Final evaluation (Day 56)

The medical team will perform a final assessment of your response to the treatment.

They will measure changes in self-injurious behaviors and overall condition.

The following will be monitored: digestive symptoms, appetite, energy levels, and general health indicators.

6 Safety monitoring

Throughout the study, the medical team will monitor for possible side effects such as:

Digestive changes (diarrhea, vomiting, appetite changes)

Energy levels (tiredness, weakness)

Physical health indicators through regular medical tests

Who Can Join the Study?

Age must be between 5 years and 17 years and 6 months
Body weight must be between 12 and 49.9 kilograms
Must have a diagnosed severe neurodevelopmental disorder with profound intellectual disability requiring help with daily activities (such as eating, dressing, using the bathroom) and constant supervision
Must have severe self-harming behaviors in the past 7 days, with either:
- One type of severe self-injury occurring at least every 3 hours while awake, or
- Two types of severe self-injuries occurring at least every 6 hours while awake
Must have tried treatment with antipsychotic medications (like Risperidone or Aripiprazole) for at least 30 days without improvement, unless these medications were not tolerated
Must have maintained the same treatments and therapies (such as physical therapy, occupational therapy, speech therapy) for at least one month
For women who can become pregnant and are sexually active: must have negative pregnancy test and use effective birth control until 18 days after treatment ends
Must have consent from both parents or legal guardians
Must have social security coverage

Who Cannot Join the Study?

History of allergic reactions to cannabidiol or similar substances
Presence of severe liver problems (as indicated by liver function tests)
Current participation in other clinical trials or within past 30 days
Use of medications that could interact with cannabidiol
Uncontrolled epilepsy (seizures that are not well managed with current treatment)
Significant changes in behavior therapy or medication in the past 3 months
Presence of severe psychiatric conditions that could affect study participation
Unstable medical conditions that could interfere with study assessments
Inability of caregivers to comply with study requirements
History of substance abuse in the immediate family environment
Pregnancy, breastfeeding, or planning to become pregnant during the study
Inability to complete required study visits and assessments
Known genetic conditions that could interfere with drug metabolism
Recent major changes in daily routine or living environment
Use of prohibited medications (certain antipsychotics, sedatives, or other central nervous system medications)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Cannabidiol

Cannabidiol (CBD) is a natural compound found in cannabis plants that does not cause psychoactive effects (it doesn’t make you feel “high”). It works with the body’s endocannabinoid system, which helps regulate various functions including mood, pain sensation, and behavior. In this trial, it is being studied to help reduce self-injurious behaviors in young patients with severe neurodevelopmental disorders. This medication is taken orally and has shown promise in managing various neurological and behavioral conditions.

Severe Neurodevelopmental Disorders – A group of conditions that affect brain development and function during early childhood and adolescence. These disorders impact multiple areas of development, including intellectual ability, behavior, and physical development. They often manifest through challenges in learning, self-care, social interaction, and communication. A notable feature can be self-injurious behaviors and stereotyped movements. The condition typically appears in early childhood and continues throughout development.

Self-Injurious Behavior – A behavioral pattern where a person deliberately causes physical harm to their own body. In the context of neurodevelopmental disorders, these behaviors can include head banging, biting oneself, or hitting oneself. This behavior pattern can be persistent and may occur alongside stereotyped movements and aggressive behaviors. The frequency and intensity of self-injurious behaviors can vary significantly among individuals.

Stereotyped Behavior – Repetitive, purposeless actions or movements that occur frequently in individuals with neurodevelopmental disorders. These behaviors can include hand flapping, rocking back and forth, or spinning objects. The movements are typically rhythmic and predictable, occurring in consistent patterns. These behaviors often appear early in development and may persist over time.

Trial ID:

2025-521161-27-00

Protocol code:

APHP240090

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of cannabidiol to reduce self-injurious behavior in children and adolescents with severe neurodevelopmental disorders

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?