Efficacy of cannabidiol
Time frame: 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.
Efficacy of cannabidiol / severity of self-injuries
Time frame: 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
Efficacy of cannabidiol / severity of self-injuries
Time frame: 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
Efficacy of cannabidiol / severity of Stereotyped behaviour
Time frame: 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
Efficacy of cannabidiol / severity of Stereotyped behaviour
Time frame: 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
Efficacy of cannabidiol / frequency of Stereotyped behaviour
Time frame: 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
Efficacy of cannabidiol / frequency of Stereotyped behaviour
Time frame: 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
Efficacy of cannabidiol / severity of Aggressive/destructive behaviour
Time frame: 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'
Efficacy of cannabidiol / severity of Aggressive/destructive behaviour
Time frame: 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'
Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour
Time frame: 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'
Efficacy of cannabidiol / frequency of Aggressive/destructive behaviour
Time frame: 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'
Efficacy of cannabidiol / the frequency of non-verbal expressions of pain
Time frame: 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
Efficacy of cannabidiol / the frequency of non-verbal expressions of pain
Time frame: 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
Efficacy of cannabidiol / quality of life
Time frame: 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
Efficacy of cannabidiol / quality of life
Time frame: 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
Efficacy of cannabidiol / stress related to the child experienced by the parents.
Time frame: 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
Efficacy of cannabidiol / stress related to the child experienced by the parents.
Time frame: 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
Safety of EPIDYOLEX®
Time frame: Day 81
serious and non-serious clinical and biological adverse events
Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain
Time frame: 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)
Correlation between the evolution of the frequency of self-injuries and the evolution of the frequency of non-verbal expressions of pain
Time frame: Day 63
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)