NCT02470325

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

June 4, 2015

Last Update Submit

August 17, 2015

Conditions

SpasticityDystonia

Keywords

Cerebral palsyGenetic neurodegenerative diseases

Outcome Measures

Primary Outcomes (1)

  • Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report

    Approximately 2 years

Secondary Outcomes (3)

  • Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire

    Approximately 2 years

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    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.

    Approximately 2 years

Study Arms (4)

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)

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)

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)

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)

Drug: Enriched Avidekel oil

Interventions

Avidekel oilDRUG

Avidekel cannabis oil 6:1 CBD:THC

Also known as: Avidekel cannabis oil
1 Avidekel3 Avidekel
Enriched Avidekel oilDRUG

Enriched Avidekel cannabis oil 20:1 CBD:THC

Also known as: Enriched Avidekel cannabis oil
2 Enriched Avidekel4 Enriched Avidekel

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participants that have been diagnosed with psychosis.
  • Abnormal ECG test results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Lubov Blumkin

Holon, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Muscle SpasticityDystoniaCerebral Palsy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Lubov Blumkin, Dr

CONTACT

972-3-5028458lubablumkin@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Luba Blumkin

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 12, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

IL(1)