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The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02470325
Recruitment Status : Unknown
Verified August 2015 by Luba Blumkin, Wolfson Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Luba Blumkin, Wolfson Medical Center

June 4, 2015
June 12, 2015
August 18, 2015
July 2015
December 2016   (Final data collection date for primary outcome measure)
Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report [ Time Frame: Approximately 2 years ]
Same as current
Complete list of historical versions of study NCT02470325 on ClinicalTrials.gov Archive Site
  • Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire [ Time Frame: Approximately 2 years ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Approximately 2 years ]
  • Comparing the scores receive from the different scales in both groups to determine the most effective cannabis oil - a ratio of 1 to 6 or 1 to 20 of Δ9 -THC to CBD. [ Time Frame: Approximately 2 years ]
Same as current
Not Provided
Not Provided
 
The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients
A Randomized Double Blind Study of Cannabis on Dystonia and Spasticity in Pediatric Patients
A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in children with neurological diseases. The clinical trial will include 40 children divided into two groups: children with spasticity and dystonia due to cerebral palsy, and children with spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various variables will be collected including: medication intake, spasticity, dystonia score, pain scale, restlessness scale, quality of life measures, safety tests, side effects, and an addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improve motor function, non-motor functions and quality of life.

The purpose of this study is to examine the effect of two cannabis oils containing the main cannabinoid Δ9 -THC and CBD ratio of 1 to 6 and 1 to 20 (respectively), on spastic movement disorder and dystonia.

40 children will be enrolled in this study and will be divided into 2 groups:

  1. Children with spasticity and dystonia due to cerebral palsy
  2. Children with spasticity and dystonia due to genetic neurodegenerative diseases

Each group will be randomly divided into two groups:

I. Active comparator: 6-to-1 ratio of CBD to THC oil II. Active comparator: 20-to-1 ratio of CBD to THC oil

During the study the following variables will be collected:

  • Consumption of drugs \ medication intake
  • Spasticity grade measured using the Modified Ashworth Scale
  • Dystonia grade measured using the Barry Albright Dystonia Scale
  • Patient's subjective report about the severity of his/her spasticity and/or dystonia
  • Pain scale
  • Restlessness scale
  • Quality of life measures: function, sleep, mood , appetite , weight
  • Safety tests: liver function, renal function, blood tests (complete blood chemistry), blood pressure, pulse, ECG
  • Side effects
  • Addiction test

The purposes of the study:

  1. Efficiency - examining the effect of cannabis on dystonia and spasticity.
  2. Examining the most effective cannabinoid ratio for the relief of dystonia and spasticity. (Δ9 -THC and CBD ratio of 1 to 6 or 1 to 20, respectively).
  3. Examining the effect of cannabis on quality of life measures (such as medication intake, mood, appetite, sleep).
  4. Safety: examination of side effects and unwanted effects of cannabis and its limitations.

Research Hypothesis: The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity symptoms in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improves motor function, non-motor function and quality of life.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Spasticity
  • Dystonia
  • Drug: Avidekel oil
    Avidekel cannabis oil 6:1 CBD:THC
    Other Name: Avidekel cannabis oil
  • Drug: Enriched Avidekel oil
    Enriched Avidekel cannabis oil 20:1 CBD:THC
    Other Name: Enriched Avidekel cannabis oil
  • Active Comparator: 1 Avidekel
    Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Avidekel oil (6-to-1 ratio of CBD to THC)
    Intervention: Drug: Avidekel oil
  • Active Comparator: 2 Enriched Avidekel
    Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC)
    Intervention: Drug: Enriched Avidekel oil
  • Active Comparator: 3 Avidekel
    Patients with spasticity and dystonia due to cerebral palsy will consume Avidekel oil (6-to-1 ratio of CBD to THC)
    Intervention: Drug: Avidekel oil
  • Active Comparator: 4 Enriched Avidekel
    Patients with spasticity and dystonia due to cerebral palsy will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC)
    Intervention: Drug: Enriched Avidekel oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
December 2017
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children ages one to 18 years old with a diagnosis of cerebral palsy or motor disability; spastic in light of neurodegenerative disease
  • Standard ECG test results and stable health condition

Exclusion Criteria:

  • Participants that have been diagnosed with psychosis.
  • Abnormal ECG test results
Sexes Eligible for Study: All
1 Year to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02470325
0101-14-WOMC
Yes
Not Provided
Not Provided
Luba Blumkin, Wolfson Medical Center
Wolfson Medical Center
Not Provided
Not Provided
Wolfson Medical Center
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP