SpasticityPhase 2NCT02470325
The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients
A Phase 2 study testing Avidekel oil and Enriched Avidekel oil in people with Spasticity and Dystonia, run by Wolfson Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Spasticity, Dystonia
- What is being tested?
- Avidekel oil and Enriched Avidekel oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Participants that have been diagnosed with psychosis.
- Abnormal ECG test results
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dr. Lubov Blumkin
Holon, Israel
Lubov Blumkin, DR., 972-5028458, lubablumkin@gmail.com
About this study
Official title: A Randomized Double Blind Study of Cannabis on Dystonia and Spasticity in Pediatric Patients
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.
Read the 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:
- 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:
- 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.
- Conditions
- Spasticity, Dystonia
- Being tested
- Avidekel oil, Enriched Avidekel oil
- Keywords
- Cerebral palsy, Genetic neurodegenerative diseases
- Medical subject headings
- Muscle Spasticity, Dystonia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avidekel oilDrug
Also called Avidekel cannabis oil
Avidekel cannabis oil 6:1 CBD:THC
Enriched Avidekel oilDrug
Also called Enriched Avidekel cannabis oil
Enriched Avidekel cannabis oil 20:1 CBD:THC
| Study group | Role | What they receive |
|---|---|---|
| 1 Avidekel | Active comparator | Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Avidekel oil (6-to-1 ratio of CBD to THC) Receives: Drug: Avidekel oil |
| 2 Enriched Avidekel | Active comparator | Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC) Receives: Drug: Enriched Avidekel oil |
| 3 Avidekel | Active comparator | Patients with spasticity and dystonia due to cerebral palsy will consume Avidekel oil (6-to-1 ratio of CBD to THC) Receives: Drug: Avidekel oil |
| 4 Enriched Avidekel | Active comparator | Patients with spasticity and dystonia due to cerebral palsy will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC) Receives: Drug: Enriched Avidekel oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report
Measured: Approximately 2 years
Secondary outcomes (3)
Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire
Measured: Approximately 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 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.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luba Blumkin, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470325
- Sponsor's protocol ID
- 0101-14-WOMC
- Status last verified
- Aug 2015
- First submitted
- 4 Jun 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Study of Cannabis on Dystonia and Spasticity in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02470325
- Acronym / sponsor ID
- 0101-14-WOMC
- Conditions
- Spasticity, Dystonia
- Keywords
- Cerebral palsy, Genetic neurodegenerative diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Avidekel | Active comparator | Drug: Avidekel oilPatients with spasticity and dystonia related to genetic neurodegenerative disease will consume Avidekel oil (6-to-1 ratio of CBD to THC) |
| 2 Enriched Avidekel | Active comparator | Drug: Enriched Avidekel oilPatients with spasticity and dystonia related to genetic neurodegenerative disease will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC) |
| 3 Avidekel | Active comparator | Drug: Avidekel oilPatients with spasticity and dystonia due to cerebral palsy will consume Avidekel oil (6-to-1 ratio of CBD to THC) |
| 4 Enriched Avidekel | Active comparator | Drug: Enriched Avidekel oilPatients with spasticity and dystonia due to cerebral palsy will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC) |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Participants that have been diagnosed with psychosis.
- Abnormal ECG test results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avidekel oilAlso: Avidekel cannabis oilAvidekel cannabis oil 6:1 CBD:THC | Drug | 1 Avidekel, 3 Avidekel |
| Enriched Avidekel oilAlso: Enriched Avidekel cannabis oilEnriched Avidekel cannabis oil 20:1 CBD:THC | Drug | 2 Enriched Avidekel, 4 Enriched Avidekel |
Primary outcome
Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report
Time frame: Approximately 2 years
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avidekel oil and Enriched Avidekel oil in people with Spasticity and Dystonia, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lubov Blumkin, Dr (972-3-5028458, lubablumkin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.