The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients

August 17, 2015 updated by: Luba Blumkin, Wolfson Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Avidekel oil
Avidekel cannabis oil 6:1 CBD:THC
Other Names:
  • Avidekel cannabis 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)
Drug: Enriched Avidekel oil
Enriched Avidekel cannabis oil 20:1 CBD:THC
Other Names:
  • Enriched Avidekel cannabis 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)
Drug: Avidekel oil
Avidekel cannabis oil 6:1 CBD:THC
Other Names:
  • Avidekel cannabis 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)
Drug: Enriched Avidekel oil
Enriched Avidekel cannabis oil 20:1 CBD:THC
Other Names:
  • Enriched Avidekel cannabis oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report
Time Frame: Approximately 2 years
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire
Time Frame: Approximately 2 years
Approximately 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Approximately 2 years
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
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0101-14-WOMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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