Trial · NCT07564245
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of cannabidiol | Day 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. |
| Secondary | Efficacy of cannabidiol | Day 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. |
| Secondary | Efficacy of cannabidiol / severity of self-injuries | Day 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 |
| Secondary | Efficacy of cannabidiol / severity of self-injuries | Day 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 |
| Secondary | Efficacy of cannabidiol / severity of Stereotyped behaviour | Day 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 |
| Secondary | Efficacy of cannabidiol / severity of Stereotyped behaviour | Day 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 |
| Secondary | Efficacy of cannabidiol / frequency of Stereotyped behaviour | Day 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 |
| Secondary | Efficacy of cannabidiol / frequency of Stereotyped behaviour | Day 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 |
| Secondary | Efficacy of cannabidiol / severity of Aggressive/destructive behaviour | Day 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' |
| Secondary | Efficacy of cannabidiol / severity of Aggressive/destructive behaviour | Day 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' |
| Secondary | Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour | Day 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 'Aggressive/destructive behaviour' |
| Secondary | Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour | Day 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 'Aggressive/destructive behaviour' |
| Secondary | Efficacy of cannabidiol / the frequency of non-verbal expressions of pain | Day 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 in GED-DI score |
| Secondary | Efficacy of cannabidiol / the frequency of non-verbal expressions of pain | Day 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 in GED-DI score |
| Secondary | Efficacy of cannabidiol / quality of life | Day 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 in QI-Disability score |
| Secondary | Efficacy of cannabidiol / quality of life | Day 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 in QI-Disability score |
| Secondary | Efficacy of cannabidiol / stress related to the child experienced by the parents. | Day 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 in Parental Stress Scale (PSS) score |
| Secondary | Efficacy of cannabidiol / stress related to the child experienced by the parents. | Day 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 in Parental Stress Scale (PSS) score |
| Secondary | Safety of EPIDYOLEX® | Day 81 | serious and non-serious clinical and biological adverse events |
| Secondary | Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain | Day 29 | Correlation between the evolution of the frequency of self-injuries (frequency score in the BPI-01 subdomain 'Self-injurious behaviour') and the evolution of the frequency of non-verbal expressions of pain (GED-DI score) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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