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Trial · NCT07564245

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

NCT07564245, Phase 2, Not yet recruiting, Assistance Publique - Hôpitaux de Paris

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders. Trials, record NCT07564245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07564245

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.
NCT number
NCT07564245
Status
Not yet recruiting
Phases
Phase 2
Enrollment
21 participants, estimated
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Conditions
Neurodevelopmental Disorders With Severe Self-injuries
Interventions
Cannabidiol
First posted
2026-05-04
Last updated
2026-05-04

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEfficacy of cannabidiolDay 63
Efficacy is evaluate by reducing the frequency of self-injuries. Cannabidiol will be considered effective at V8 Day 63 in clinically significant reductions in the frequency of self-injuries if the frequency score on the 'Self-injurious behaviour subdomain of the BPI-01 is reduced by 30% or more at the V8 Day 63 visit compared to the V2 Day 0 visit.
SecondaryEfficacy of cannabidiolDay 29
Cannabidiol will be considered effective at Visit6 Day29 in clinically significant reduction in the frequency of self-injuries if the frequency score in the 'Self-injurious behaviour' sub-domain of the BPI-01 is reduced by 30% or more at the Visit6 Day29 visit compared with the Visit2 Day 0 visit.
SecondaryEfficacy of cannabidiol / severity of self-injuriesDay 29
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day29. For this criteria: severity score in the 'Self-injurious behaviour' sub-domain of BPI-01
SecondaryEfficacy of cannabidiol / severity of self-injuriesDay 63
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63. For this criteria: severity score in the 'Self-injurious behaviour' sub-domain of BPI-01
SecondaryEfficacy of cannabidiol / severity of Stereotyped behaviourDay 29
The efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day0 and visits V6 Day29. For this criteria: severity score for the BPI-01 sub-domain 'Stereotyped behaviour
SecondaryEfficacy of cannabidiol / severity of Stereotyped behaviourDay 63
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63. For this criteria: severity score for the BPI-01 sub-domain 'Stereotyped behaviour
SecondaryEfficacy of cannabidiol / frequency of Stereotyped behaviourDay 29
The efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29. For this criteria: frequency score for the BPI-01 sub-domain 'Stereotyped behaviour
SecondaryEfficacy of cannabidiol / frequency of Stereotyped behaviourDay 63
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63. For this criteria: frequency score for the BPI-01 sub-domain 'Stereotyped behaviour
SecondaryEfficacy of cannabidiol / severity of Aggressive/destructive behaviourDay 29
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V6 Day 29. For this criteria: severity score for the BPI-01 sub-domain 'Aggressive/destructive behaviour'
SecondaryEfficacy of cannabidiol / severity of Aggressive/destructive behaviourDay 63
the efficacy of the treatment will be assessed by the percentage change in percentage scores between visit V2 Day 0 and visits V8 Day 63. For this criteria: severity score for the BPI-01 sub-domain 'Aggressive/destructive behaviour'

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07564245

GET https://conductscience.org/api/trials/v1/NCT07564245/registered?page=2