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Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

NCT03690791 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-04-03

No results posted yet for this study

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

Interventions

DRUG

MediCabilis CBD Oil

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

DRUG

Placebo Oil

Placebo will contain only hemp seed oil.

Sponsors & Collaborators

  • Bod Australia

    collaborator INDUSTRY

  • Gold Coast Hospital and Health Service

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2023-12-30
Completion
2024-01-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690791 on ClinicalTrials.gov