The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients

Dystonia Clinical Trial

Official title:

A Randomized Double Blind Study of Cannabis on Dystonia and Spasticity in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02470325
• Other study ID #: 0101-14-WOMC
• Status: Recruiting
• Phase: Phase 2
• First received: June 4, 2015
• Last updated: August 17, 2015
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2015
• Source: Wolfson Medical Center
• Contact: Lubov Blumkin, Dr
• Phone: 972-3-5028458
• Email: lubablumkin[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Muscle Spasticity
• Spasticity

Intervention

Drug:
• Avidekel oil
Avidekel cannabis oil 6:1 CBD:THC
• Enriched Avidekel oil
Enriched Avidekel cannabis oil 20:1 CBD:THC

Locations

Country	Name	City	State
Israel	Dr. Lubov Blumkin	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report		Approximately 2 years	No
Secondary	Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire		Approximately 2 years	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Approximately 2 years	Yes
Secondary	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 ?9 -THC to CBD.		Approximately 2 years	No