Study of Sativex in Children (aged 8-18) with Severe Spasticity
Research type
Research Study
Full title
THE EFFICACY, SAFETY AND TOLERABILITY OF SATIVEX AS AN ADJUNCTIVE TREATMENT TO EXISTING ANTI-SPASTICITY MEDICATIONS IN CHILDREN AGED 8 TO 18 YEARS WITH SPASTICITY DUE TO CEREBRAL PALSY OR TRAUMATIC CENTRAL NERVOUS SYSTEM INJURY WHO HAVE NOT RESPONDED ADEQUATELY TO THEIR EXISTING ANTI-SPASTICITY MEDICATIONS: A PARALLEL GROUP RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION PHASE.
IRAS ID
129722
Contact name
Charlie Fairhurst
Contact email
Sponsor organisation
GW Pharma Ltd
Eudract number
2012-003771-18
ISRCTN Number
N/A
Research summary
This study is being conducted by GW Pharma Ltd. to determine the efficacy, safety and tolerability of Sativex in a population of children and adolescents aged from 8 to 18 years with severe spasticity due to Cerebral Palsy or traumatic central nervous system injury whose current anti-spasticity medication is not adequately addressing their needs.
This study is split into two parts, a 12-week randomised part and a 24-week open-label extension part.
At the start of the study the primary caregivers are instructed on how to complete the daily diary where the spasticity Numeric Rating Scale (NRS), sleep NRS and the daily comfort questionnaire are recorded. All those who meet the entry criteria are randomised one week later, at Visit 2 (Day 0) to receive either Sativex or placebo (2:1).
Following the final assessment of the randomised phase of the study (Visit 9), all children will be offered the chance to continue into an open-label extension phase where they will receive Sativex for a maximum period of 24 weeks. During this time they will be assessed at 56 day intervals. Study-related observations will also take place at each assessment visit and will include: physical examination, vital signs, weight, adverse events (AEs), laboratory tests (at end of treatment visit only) and concomitant medications. For participants who decide not to participate in the extension phase there will be a safety follow-up telephone contact visit at Day 98 (Visit 10). The study has been designed to align the visits with the usual clinic visits that would take place when children start a new intervention.
All concomitant anti-spasticity medications will be continued at the same dose throughout the study, or may be reduced in the event of AEs which are attributed to the concomitant medication.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0201
Date of REC Opinion
6 Aug 2013
REC opinion
Further Information Favourable Opinion