The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients
Keywords
Abstract
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.
Dates
| Last Verified: | 07/31/2015 |
| First Submitted: | 06/03/2015 |
| Estimated Enrollment Submitted: | 06/08/2015 |
| First Posted: | 06/11/2015 |
| Last Update Submitted: | 08/16/2015 |
| Last Update Posted: | 08/17/2015 |
| Actual Study Start Date: | 06/30/2015 |
| Estimated Primary Completion Date: | 11/30/2016 |
| Estimated Study Completion Date: | 11/30/2017 |
Condition or disease
Intervention/treatment
Drug: Avidekel oil
Drug: Enriched Avidekel oil
Phase
Arm Groups
| 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) | |
| 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) | |
| 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) | |
| 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) |
Eligibility Criteria
| Ages Eligible for Study | 1 Year To 1 Year |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report [Approximately 2 years]
Secondary Outcome Measures
1. Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire [Approximately 2 years]
2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Approximately 2 years]
3. 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. [Approximately 2 years]
