EUCTR2012-003771-18-GBActive, not recruitingPhase 1
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. - Not Applicable
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GW Pharma Ltd.
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •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.
Investigators
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