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CBD-SIB - Efficacy of cannabidiol in the management of Self-Injurious Behavior in children and adolescents with severe neurodevelopmental disorders
EU CTIS ID: 2025-521161-27-00
What this study is testing
To evaluate the efficacy of cannabidiol in reducing the frequency of self-injuries at D56 in children and adolescents with severe neurodevelopmental disorders
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age between 5 years and 17 years 6 months;
- Weight between 12 and 49.9 kg;
- Clinical diagnosis of severe neurodevelopmental disorder including severe to profound intellectual developmental disorder, characterized in the DSM-5 by a need for help with any daily activity (meals, dressing, toileting, elimination) and the need for constant supervision;
- Severe self-injuries during the last 7 days defined by BPI-01, i.e.: a. at least one type of self-injuries assessed as severe intensity occurring at least once every 3 hours while awake or b. at least two types of self-injuries assessed as severe intensity occurring at least once every 6 hours each while awake;
- Self-injuries refractory to treatment with atypical neuroleptic (RISPERIDONE, ARIPIPRAZOLE, etc.) at a dosage deemed effective by the investigator in view of the patient's weight, age and background, for a minimum duration of 30 days (except in the case of poor tolerance by the patient);
- No change in drug and non-drug treatments such as rehabilitative care (psychomotricity, occupational therapy, speech therapy, intervention by a specialist educator) for at least one month;
You likely can't join if
- Hypersensitivity to the active substance (cannabidiol) or to any of the excipients (refined sesame oil, anhydrous ethanol, sucralose, strawberry flavor, benzyl alcohol);
- Pregnancy or breastfeeding;
- Inability of the patient or entourage to comply with the study protocol;
- Participation in other interventional research, clinical trial or clinical investigation
- Treatment with or consumption of cannabidiol in the 12 weeks prior to inclusion;
- Consumption of cannabis in the 12 weeks prior to inclusion;
See the full eligibility criteria
Who can join
- 1. Age between 5 years and 17 years 6 months;
- Weight between 12 and 49.9 kg;
- Clinical diagnosis of severe neurodevelopmental disorder including severe to profound intellectual developmental disorder, characterized in the DSM-5 by a need for help with any daily activity (meals, dressing, toileting, elimination) and the need for constant supervision;
- Severe self-injuries during the last 7 days defined by BPI-01, i.e.: a. at least one type of self-injuries assessed as severe intensity occurring at least once every 3 hours while awake or b. at least two types of self-injuries assessed as severe intensity occurring at least once every 6 hours each while awake;
- Self-injuries refractory to treatment with atypical neuroleptic (RISPERIDONE, ARIPIPRAZOLE, etc.) at a dosage deemed effective by the investigator in view of the patient's weight, age and background, for a minimum duration of 30 days (except in the case of poor tolerance by the patient);
- No change in drug and non-drug treatments such as rehabilitative care (psychomotricity, occupational therapy, speech therapy, intervention by a specialist educator) for at least one month;
- In WOCBP and with active sexual life: negatives hCG and use of highly effective contraceptive measure until 18 days after the end of the treatment.
- Consent of both holders of parental authority;
- Affiliation to social security regimen.
What rules you out
- Hypersensitivity to the active substance (cannabidiol) or to any of the excipients (refined sesame oil, anhydrous ethanol, sucralose, strawberry flavor, benzyl alcohol);
- Pregnancy or breastfeeding;
- Inability of the patient or entourage to comply with the study protocol;
- Participation in other interventional research, clinical trial or clinical investigation
- Treatment with or consumption of cannabidiol in the 12 weeks prior to inclusion;
- Consumption of cannabis in the 12 weeks prior to inclusion;
- Usual treatment (excluding treatment of self-injuries) containing molecules interacting with cannabidiol (rifampicin, carbamazepine, enzalutamide, mitotane, St. John's wort, clobazam, valproate, stiripentol, phenytoin, lamotrigine, everolimus, theophylline, tizanidine, bupropion, efavirenz, diflunisal, propofol, fenofibrate, gemfibrozil, morphine, lorazepam, repaglinide, warfarin, sirolimus, tacrolimus, digoxin);
- Elevated transaminases > 3N or total bilirubin > 2N;
- Known current heart failure;
- Known current terminal renal failure (GFR < 15 ml/min/1.73 m2);
- Known current moderate or severe hepatic insufficiency (Child-Pugh B or C);
- Known current epilepsy or history of epilepsy, even stabilized, requiring treatment currently or not, whatever the type;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.