Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease
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|ClinicalTrials.gov Identifier: NCT03690791|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : July 28, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis Motor Neuron Disease||Drug: MediCabilis CBD Oil Drug: Placebo Oil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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, 2022|
|Estimated Study Completion Date :||January 30, 2023|
|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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||25 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Affected by ALS/MND, either of definite or probable according to the El Escorial revised criteria
- Can provide written informed consent
- Able and willing to comply with all study requirement
- Male or female, ages 25-80 years old
- Onset of first symptom within the last 2 years
- Forced Vital Capacity (FVC) of at least 60% on baseline
- Participants who are bedridden
- Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry
- History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
- Heavy consumption of alcohol or use of illicit drug
- Hypersensitivity to cannabinoids or any of the excipients
- Any of the following: eGFR <30 mL/min/1.73m2, ejection fraction <35%, or ASL and ALT >5 X ULN
- Unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
- Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
- Received any investigational drug or medical device within 30 days prior randomisation
- 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
- Inability to cooperate with the study procedures
- Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
- Close affiliation with the study team, e.g. close relative of the investigator
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
|Contact: Arman Sabet, MD||+61 1300 744 284||Arman.Sabet@health.qld.gov.au|
|Contact: Berzenn Urbi, RN||+61 1300 744 284||Berzenn.Urbi@health.qld.gov.au|
|Gold Coast Hospital and Health Service||Recruiting|
|Gold Coast, Queensland, Australia, 4215|
|Contact: Arman Sabet, MD +61 1300 744 284 Arman.Sabet@health.qld.gov.au|
|Responsible Party:||Gold Coast Hospital and Health Service|
|Other Study ID Numbers:||
|First Posted:||October 1, 2018 Key Record Dates|
|Last Update Posted:||July 28, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
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.
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases