NCT01898520

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2013

Typical duration for phase_3

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

2.8 years

First QC Date

July 10, 2013

Last Update Submit

December 19, 2022

Conditions

Cerebral Palsy

Keywords

Spasticity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score

    The spasticity 0-10 NRS was completed daily at bedtime using a paper study diary. The difference between spasticity and spasm was clearly explained to the caregiver. The primary caregiver was asked the following question: "This question is about your child's muscles and how soft or tight/hard they have felt today. Think carefully about how your child's muscles have felt today and circle a number from 0 to 10 that best describes this, where: 0 = 'my child's muscles have felt totally relaxed' and 10 = 'my child's muscles have felt the tightest/hardest they have ever felt'". A reduction in score indicates an improvement in condition. The mean spasticity 0-10 NRS score of the last 7 days of the baseline period was used for a patient's mean baseline score. The mean 0-10 NRS score of the last 7 days prior to completion/withdrawal was used for a patient's mean end of treatment score.

    Day 0 - Day 84

Secondary Outcomes (11)

  • Change from baseline to the end of 12 weeks' treatment in mean MTS score of the most affected limb

    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

    Day 0 - Day 84

  • Change from baseline to the end of 12 weeks' treatment in mean sleep quality 0-10 NRS score

    Day 0 - Day 84

  • Change from baseline to the end of 12 weeks' treatment in mean Paediatric Pain Profile (PPP) score

    Day 0 - Day 84

  • Change from baseline to the end of 12 weeks' treatment in mean cerebral palsy QOL score

    Day 0 - Day 84

  • +6 more secondary outcomes

Study Arms (2)

Sativex

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.

Drug: Sativex

Placebo

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.

Drug: Placebo

Interventions

SativexDRUG

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.

Also known as: Nabiximols, THC:CBD spray, GW-1000-02
Sativex
PlaceboDRUG

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.

Also known as: GW-4000-01
Placebo

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Center 14

Prague, Czechia

Location

Center 7

Tel Aviv, Israel

Location

Center 8

Tel Litwinsky, Israel

Location

Center 2

Bristol, United Kingdom

Location

Center 6

Cambridge, United Kingdom

Location

Center 10

Exeter, United Kingdom

Location

Center 13

Glasgow, United Kingdom

Location

Center 3

Liverpool, United Kingdom

Location

Center 1

London, United Kingdom

Location

Center 5

London, United Kingdom

Location

Center 12

Norwich, United Kingdom

Location

Center 9

Nottingham, United Kingdom

Location

Center 11

Salisbury, United Kingdom

Location

Center 4

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 12, 2013

Study Start

December 1, 2013

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

IL(2)GB(11)CZ(1)