The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 2

Conditions: Spasticity; Dystonia

Treatments: Drug: Avidekel oil; Drug: Enriched Avidekel oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02470325

0101-14-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

1 Avidekel

Active Comparator group

Description:

Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Avidekel oil (6-to-1 ratio of CBD to THC)

Treatment:

Drug: Avidekel oil

2 Enriched Avidekel

Active Comparator group

Description:

Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC)

Treatment:

Drug: Enriched Avidekel oil

3 Avidekel

Active Comparator group

Description:

Patients with spasticity and dystonia due to cerebral palsy will consume Avidekel oil (6-to-1 ratio of CBD to THC)

Treatment:

Drug: Avidekel oil

4 Enriched Avidekel

Active Comparator group

Description:

Patients with spasticity and dystonia due to cerebral palsy will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC)

Treatment:

Drug: Enriched Avidekel oil