Not Yet RecruitingPhase 2

Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.

France21 participantsStarted 2026-05

Plain-language summary

Self-injuries includes repetitive actions directed at oneself, such as biting, hitting, hitting one's head or limbs, slapping oneself, pulling one's hair, or hitting oneself in the eyes, which can lead to severe injury. They are commonly reported in many neurodevelopmental disorders associated with intellectual development disorders. Faced with the difficulty of treating these self-mutilations, it seems essential to be able to explore new therapeutic avenues. Today, in the rare disease reference centers of the Necker-Enfants malades hospital, neuropathic pain in children, especially those suffering from genetic diseases with skin expression such as primary erythermalgia, is successfully and safely treated with cannabidiol in the event of failure of conventional therapies. It seems essential to be able to confirm the effectiveness of cannabidiol in treating self-injuries in children with neurodevelopmental disorders, and to help understand the mechanisms of action that underlie it. We hypothesize that the nociceptive system is involved in the occurrence of self-injuries and as a target of action of cannabidiol to treat it.

Who can participate

Age range5 Years – 17 Years

SexALL

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Inclusion criteria

✓. 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.:
✓. at least one type of self-injuries assessed as severe intensity occurring at least once every 3 hours while awake or
✓. 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;

What they're measuring

Efficacy of cannabidiol

Timeframe: Day 63

Trial details

NCT IDNCT07564245

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05

Contact for this trial

Pauline CHASTE, MD; PhD

01 44 49 57 59 pauline.chaste@aphp.fr

View on ClinicalTrials.gov More Neurodevelopmental Disorders With Severe Self-injuries trials