NCT03690791

Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Gold Coast Hospital and Health Service · Other Government
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-09
• Primary completion: 2023-12-30
• Completion: 2024-01-30
• First posted: 2018-10-01
• Last updated: 2023-04-03

Locations

1 site across 1 country: Australia