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Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

Primary Purpose

Amyotrophic Lateral Sclerosis, Motor Neuron Disease

Status

Active

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

MediCabilis CBD Oil

Placebo Oil

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Gold Coast Hospital and Health Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MediCabilis CBD Oil

Placebo Oil

Arm Description

Outcomes

Primary Outcome Measures

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]

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]

Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks

Secondary Outcome Measures

Nature and number of adverse events [safety and tolerability]

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)

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)

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)

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)

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.

Full Information

NCT ID

NCT03690791

First Posted

September 13, 2018

Last Updated

March 30, 2023

Sponsor

Gold Coast Hospital and Health Service

Collaborators

Bod Australia

1. Study Identification

Unique Protocol Identification Number

NCT03690791

Brief Title

Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 9, 2019 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gold Coast Hospital and Health Service

Collaborators

Bod Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis, Motor Neuron Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MediCabilis CBD Oil

Arm Type

Active Comparator

Arm Title

Placebo Oil

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MediCabilis CBD Oil

Intervention Description

50 mg of CBD: <2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil.

Intervention Type

Drug

Intervention Name(s)

Placebo Oil

Intervention Description

Placebo will contain only hemp seed oil.

Primary Outcome Measure Information:

Title

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]

Description

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.

Time Frame

Baseline to Day 180

Title

Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy]

Description

Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks

Time Frame

Baseline to Day 180

Secondary Outcome Measure Information:

Title

Nature and number of adverse events [safety and tolerability]

Description

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks

Time Frame

Baseline to Day 180

Title

Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100)

Description

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.

Time Frame

Baseline to Day 180

Title

Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100)

Description

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.

Time Frame

Baseline to Day 180

Title

Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100)

Description

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.

Time Frame

Baseline to Day 180

Title

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)

Description

Time Frame

Baseline to Day 180

Other Pre-specified Outcome Measures:

Title

Difference in mean Edinburgh Cognitive and Behavioural ALS Screen (ECAS) total score between groups at end of treatment (Score 0-136)

Description

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.

Time Frame

Baseline to Day 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Gold Coast Hospital and Health Service

City

Gold Coast

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

31719072

Citation

Urbi B, Broadley S, Bedlack R, Russo E, Sabet A. Study protocol for a randomised, double-blind, placebo-controlled study evaluating the Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease: the EMERALD trial. BMJ Open. 2019 Nov 11;9(11):e029449. doi: 10.1136/bmjopen-2019-029449.

Results Reference

derived

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Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

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