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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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Spasticity Dystonia Drug: Avidekel oil Drug: Enriched Avidekel oil Phase 2

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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Study of Cannabis on Dystonia and Spasticity in Pediatric Patients
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia Marijuana
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: 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 Name: Enriched Avidekel cannabis oil


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report [ Time Frame: Approximately 2 years ]

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470325


Contacts
Contact: Lubov Blumkin, Dr 972-3-5028458 lubablumkin@gmail.com

Locations
Israel
Dr. Lubov Blumkin Recruiting
Holon, Israel
Contact: Lubov Blumkin, DR.    972-5028458    lubablumkin@gmail.com   
Sponsors and Collaborators
Wolfson Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Luba Blumkin, Dr. Luba Blumkin, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02470325     History of Changes
Other Study ID Numbers: 0101-14-WOMC
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

Keywords provided by Luba Blumkin, Wolfson Medical Center:
Cerebral palsy
Genetic neurodegenerative diseases

Additional relevant MeSH terms:
Muscle Spasticity
Dystonia
Dystonic Disorders
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dyskinesias
Movement Disorders
Central Nervous System Diseases