We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690791
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : April 3, 2023
Sponsor:
Collaborator:
Bod Australia
Information provided by (Responsible Party):
Gold Coast Hospital and Health Service

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (MediCabilis CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive MediCabilis CBD Oil or placebo oil. The treatment duration is 6 months with one-month safety follow up. Participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as ALSFRS-R, Forced Vital Capacity, pain and spasticity score, and quality of life. Thirty (30) participants will be randomised.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Motor Neuron Disease Drug: MediCabilis CBD Oil Drug: Placebo Oil Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: MediCabilis CBD Oil Drug: MediCabilis CBD Oil
50 mg of CBD: <2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil.
Placebo Comparator: Placebo Oil Drug: Placebo Oil
Placebo will contain only hemp seed oil.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference in mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score between groups at end of treatment (Total score: min 0- max 48) [efficacy] [ Time Frame: Baseline to Day 180 ]
    Change from baseline in ALS functional rating total scores on the ALSFRS-R at 24 weeks. Total score ranges from 0 to 48. Higher value represents better outcome.

  2. Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy] [ Time Frame: Baseline to Day 180 ]
    Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks


Secondary Outcome Measures :
  1. Nature and number of adverse events [safety and tolerability] [ Time Frame: Baseline to Day 180 ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks

  2. Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100) [ Time Frame: Baseline to Day 180 ]
    Change from baseline in spasticity total score on the Numeric Rating Scale for spasticity at 24 weeks. Total score ranges from 0 to 100. Higher values represent better outcome.

  3. Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100) [ Time Frame: Baseline to Day 180 ]
    Change from baseline in pain total score on the Numeric Rating Scale for pain at 24 weeks. Total score ranges from 0 to 100. Higher value represents better outcome.

  4. Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100) [ Time Frame: Baseline to Day 180 ]
    Change from baseline in weight loss on the Percentage of Total Weight Loss at 24 weeks. Percentage ranges from 0 to 100. Higher value represents better outcome.

  5. Difference in mean ALS Specific Quality of Life- Revised (ALSSQOL-R) total score between groups at end of treatment (Total score min:0- max:460) [ Time Frame: Baseline to Day 180 ]
    Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) score at 24 weeks. Total score ranges from 0 to 460. Higher score represent better outcome.


Other Outcome Measures:
  1. Difference in mean Edinburgh Cognitive and Behavioural ALS Screen (ECAS) total score between groups at end of treatment (Score 0-136) [ Time Frame: Baseline to Day 180 ]
    Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) total score at 24 weeks. Total score ranges from 0 to 100. Higher score represent better outcome.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Affected by ALS/MND, either of definite or probable according to the El Escorial revised criteria
  2. Can provide written informed consent
  3. Able and willing to comply with all study requirement
  4. Male or female, ages 25-80 years old
  5. Onset of first symptom within the last 2 years
  6. Forced Vital Capacity (FVC) of at least 60% on baseline

Exclusion Criteria:

  1. Participants who are bedridden
  2. Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry
  3. History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
  4. Heavy consumption of alcohol or use of illicit drug
  5. Hypersensitivity to cannabinoids or any of the excipients
  6. Any of the following: eGFR <30 mL/min/1.73m2, ejection fraction <35%, or ASL and ALT >5 X ULN
  7. Unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
  8. Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
  9. Received any investigational drug or medical device within 30 days prior randomisation
  10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
  11. Inability to cooperate with the study procedures
  12. Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
  13. Close affiliation with the study team, e.g. close relative of the investigator
Contacts and Locations
Go to 
Top of Page 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): NCT03690791


Locations
Layout table for location information
Australia, Queensland
Gold Coast Hospital and Health Service
Gold Coast, Queensland, Australia, 4215
Sponsors and Collaborators
Gold Coast Hospital and Health Service
Bod Australia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Gold Coast Hospital and Health Service
ClinicalTrials.gov Identifier: NCT03690791    
Other Study ID Numbers: GCMR0001
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.

Additional data can be requested from the authors. However, the decision to disclose data is solely based from authors' discretion and funding agency.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases