Overview

This trial is active, not recruiting.

Condition cerebral palsy
Treatments sativex, placebo
Phase phase 3
Sponsor GW Research Ltd
Start date December 2013
End date September 2016
Trial size 72 participants
Trial identifier NCT01898520, GWSP08258

Summary

A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Oromucosal spray containing delta-9-tetrahydrocannabinol (THC) (27 mg/mL):cannabidiol (CBD) (25 mg/mL). Each 100 μL spray to the sub-lingual or oral mucosa delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12.
sativex Nabiximols
Oromucosal spray containing THC (27 mg/mL):CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12.
(Placebo Comparator)
Oromucosal spray containing ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum number of daily sprays was 12.
placebo GW-4000-01
Oromucosal spray containing ethanol: propylene glycol(50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum daily dose was 12 sprays per day.

Primary Outcomes

Measure
Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score
time frame: Day 0 - Day 84

Secondary Outcomes

Measure
Change from baseline to the end of 12 weeks' treatment in mean MTS score of the most affected limb
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean MAS score of the main muscle groups of the upper and lower limb
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean sleep quality 0-10 NRS score
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean Paediatric Pain Profile (PPP) score
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean cerebral palsy QOL score
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean comfort questionnaire outcome (time spent sitting in comfort)
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean CDI 2 score
time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean caregiver QOL (SF-36-II) score
time frame: Day 0 - Day 84
CGIC response on participants general functional capabilities at the end of 12 weeks' treatment
time frame: Day 84
CGIC response on participants ease of transfer at the end of 12 weeks' treatment
time frame: Day 84
The incidence of adverse events during the randomised treatment period
time frame: Day 0 - Day 84

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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 willing and able to give informed consent for participation in the study. - To have been under treatment for their spasticity for at least one year and to have reached a stage of non-progressive spasticity. - Participant 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 Level III - V. - MAS of two or higher in at least one muscle group. - Participant and/or authorised representative willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries. - Participant and/or authorised representative willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion Criteria: - Any known or suspected history of: - Schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative. - Alcohol or substance abuse. - Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s) - Use of cannabis or cannabinoid based medications (including within 30 days or 60 days of study entry respectively). - Weight less than 15 kg. - Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. - Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. - Participants who have received an Investigational Medicinal Product (IMP) within the 12 weeks prior to the screening visit. - Has been treated with botulinum toxin in the previous 12 weeks. - Concomitant use of botulinum toxin - 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. - Significant cardiac, renal or hepatic disease. - 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. - Unwilling to abstain from donation of blood during the study

Additional Information

Official 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
Principal investigator Charles Fairhurst, BSc MSc MBBS MRCP FRCPCH
Description A 12 week randomised, double-blind, placebo-controlled,parallel group study followed by a 24-week open-label extension phase. The primary objective is to assess the efficacy of Sativex treatment using a spasticity 0-10 numerical rating scale (NRS). The endpoint for analysis is the comparison between Sativex and placebo in the change from baseline to the end of the acute phase in mean spasticity 0-10 NRS scores (week 12 or last seven days prior to withdrawal). The secondary objectives are to assess the safety and tolerability of Sativex via volunteered adverse events, laboratory parameters and vital signs. The efficacy of Sativex compared to placebo is also investigated for the following outcomes: spasticity (modified tardieu scale (MTS) score of the most affected limb and the modified ashworth scale (MAS) score of the main muscle groups of the upper and lower limb), sleep quality (sleep 0-10 NRS), pain (paediatric pain profile [PPP]), quality of life (of both the participant and the caregiver; cerebral palsy quality of life (QOL) questionnaire and caregiver QOL questionnaire), comfort (comfort questionnaire), depression assessment (childrens depression inventory (CDI 2)) and the caregiver's global impression of change (CGIC).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by GW Research Ltd.