Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    30
  • sponsor
    Gold Coast Hospital and Health Service
Updated on 5 March 2022
spasticity
cannabinoids
primary lateral sclerosis
motor neuron disease
amyotrophic lateral sclerosis

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.

Details
Condition Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Treatment Placebo oil, MediCabilis CBD Oil
Clinical Study IdentifierNCT03690791
SponsorGold Coast Hospital and Health Service
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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