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A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years

NCT01898520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-12-20

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

DRUG

Sativex

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.

DRUG

Placebo

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-09-30
Completion
2017-03-31

Countries

  • Czechia
  • Israel
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898520 on ClinicalTrials.gov