Study of cannabidiol to reduce self-injurious behavior in children and adolescents with severe neurodevelopmental disorders
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- 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 trial?
15 criteria
- 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)
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Investigated drugs
What is already known about the treatment
Investigated diseases
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.
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