Spasticity due to cerebral palsy (CP) or traumatic central nervous system injury. MedDRA version: 18.1 Level: PT Classification code 10028335 Term: Muscle spasticity System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Sativex Oromucosal Spray
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: N/A
CAS Number: 1972-08-3
Other descript
Sponsors
GW Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males and females aged between 8 and 18 years suffering from Cerebral Palsy or traumatic central nervous system injury. • Participant and/or authorised representative is willing and able to give informed consent for participation in the study. • Participant is able (in the investigators opinion) and willing to comply with all study requirements. • Participant has received inadequate efficacy and/or experienced unacceptable side effects from previous or current treatment with at least one of the following medications for spasticity: Baclofen, Diazepam (or another benzodiazepine) Dantrolene, Tizanidine, Gabapentin, Trihexyphenidyl. • Gross Motor Function Classification Scale (GMFCS) Level III – V. • MAS of two or higher in at least one muscle group. Are the trial subjects under 18? yes Number of subjects for this age range: 72 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Any known or suspected history of: o Schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative. o Alcohol or substance abuse. • Participants who have received an IMP within the 12 weeks prior to the screening visit. • Any other significant disease or disorder, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or the participant’s ability to participate in the study. • Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study. • Unwilling to abstain from donation of blood during the study. • Hypersensitivity to cannabinoids or any of the excipients of the IMP. • Significant cardiac, renal or hepatic disease. • Weight less than 15 kg. • Has been treated with botulinum toxin in the previous 12 weeks. • Concomitant use of botulinum toxin. • Planned surgical procedure during the randomised phase of the study. • Travel outside the country of residence planned during the study. • Participants previously randomised into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Sativex on spasticity in a population of children and adolescents aged from 8 to 18 years with CP or traumatic central nervous system injury.; Secondary Objective: To assess the safety and tolerability of Sativex in a population of children and adolescents aged from 8 to 18 years with CP or traumatic central nervous system injury. To assess the efficacy of Sativex compared to placebo on change in spasticity, sleep, pain, quality of life (of both the participant and the caregiver), comfort, depression assessment and the caregiver’s global impression of change. ;Primary end point(s): Spasticity NRS (0 - 10). This will be entered into the participant’s diary which is to be completed daily throughout the randomised study period, and weekly throughout the open-label phase. The endpoint for analysis will be the comparison between Sativex and placebo in the change in NRS from baseline to the end of the acute phase (Week 12 or last 7 days prior to withdrawal).;Timepoint(s) of evaluation of this end point: Evaluated daily in a diary for the first 12 weeks and weekly in a diary for the following 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Modified Tardieu Scale (MTS) score of the most affected limb - Modified Ashworth Scale (MAS) score of the main muscle groups - Sleep quality* - Paediatric Pain profile (PPP) - CP Quality of Life (QOL) questionnaire - Change in comfort* - Children’s Depression Inventory 2 (CDI 2) - Caregiver QOL questionnaire - Caregiver Global Impression of Change (CGIC) Safety endpoints (AEs, laboratory parameters and vital signs) ;Timepoint(s) of evaluation of this end point: Evaluated at each assessment visit (Day -7; 0; 28; 56; 84; 140; 196 and 252) or assessed on a daily or weekly basis in the diary (*). | — |
Countries
Czech Republic, Israel, United Kingdom
Contacts
Public ContactGW Pharma Ltd. Switchboard
GW Pharma Ltd.
Outcome results
None listed