The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients
NCT ID: NCT02470325
Last Updated: 2015-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2015-07-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1 Avidekel
Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Avidekel oil (6-to-1 ratio of CBD to THC)
Avidekel oil
Avidekel cannabis oil 6:1 CBD:THC
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)
Enriched Avidekel oil
Enriched Avidekel cannabis oil 20:1 CBD:THC
3 Avidekel
Patients with spasticity and dystonia due to cerebral palsy will consume Avidekel oil (6-to-1 ratio of CBD to THC)
Avidekel oil
Avidekel cannabis oil 6:1 CBD:THC
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)
Enriched Avidekel oil
Enriched Avidekel cannabis oil 20:1 CBD:THC
Interventions
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Avidekel oil
Avidekel cannabis oil 6:1 CBD:THC
Enriched Avidekel oil
Enriched Avidekel cannabis oil 20:1 CBD:THC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Standard ECG test results and stable health condition
Exclusion Criteria
* Abnormal ECG test results
1 Year
18 Years
ALL
No
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Luba Blumkin
Dr. Luba Blumkin
Locations
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Dr. Lubov Blumkin
Holon, Israel, Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0101-14-WOMC
Identifier Type: -
Identifier Source: org_study_id
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