Clinical Trial

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

Study acronym: CBD-SIB
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07564245
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin, Fondation Perce Neige
Conditions Neurodevelopmental Disorders With Severe Self-injuries
Enrollment 21 participants
Start Date 2026-05
Primary Completion 2029-05 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-04