Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

NCT ID: NCT03690791

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2024-01-30

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.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MediCabilis CBD Oil

Group Type: ACTIVE_COMPARATOR

MediCabilis CBD Oil

Intervention Type: DRUG

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

Placebo Oil

Group Type: PLACEBO_COMPARATOR

Placebo Oil

Intervention Type: DRUG

Placebo will contain only hemp seed oil.

Interventions

MediCabilis CBD Oil

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

Intervention Type: DRUG

Placebo Oil

Placebo will contain only hemp seed oil.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bod Australia

INDUSTRY

Sponsor Role: collaborator

Gold Coast Hospital and Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gold Coast Hospital and Health Service

Gold Coast, Queensland, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 31719072 (View on PubMed)

Other Identifiers

GCMR0001

Identifier Type: -

Identifier Source: org_study_id