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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spasticity Dystonia | Drug: Avidekel oil Drug: Enriched Avidekel oil | Phase 2 |
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:
- Children with spasticity and dystonia due to cerebral palsy
- 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:
- Efficiency - examining the effect of cannabis on dystonia and spasticity.
- 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).
- Examining the effect of cannabis on quality of life measures (such as medication intake, mood, appetite, sleep).
- 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 (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 |

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 |
- Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report [ Time Frame: Approximately 2 years ]
- Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire [ Time Frame: Approximately 2 years ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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 ]

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Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Lubov Blumkin, Dr | 972-3-5028458 | lubablumkin@gmail.com |
Israel | |
Dr. Lubov Blumkin | Recruiting |
Holon, Israel | |
Contact: Lubov Blumkin, DR. 972-5028458 lubablumkin@gmail.com |
Responsible Party: | Luba Blumkin, Dr. Luba Blumkin, Wolfson Medical Center |
ClinicalTrials.gov Identifier: | NCT02470325 |
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 |
Cerebral palsy Genetic neurodegenerative diseases |
Muscle Spasticity Dystonia Dystonic Disorders Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia |
Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Dyskinesias Movement Disorders Central Nervous System Diseases |