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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
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  • Published on:
    Emerald trial disclaimer update
    • Berzenn Urbi, Researcher/Research Coordinator Gold Coast University Hospital

    CORRECTION/DISCLAIMER. As of the date of publication of the 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 (the “Study”), CannTrust Inc. (“CannTrust”) had received a Notice of Licence Suspension pursuant to the Cannabis Act (Canada). The Notice states that Health Canada has suspended CannTrust's authority to produce cannabis, other than cultivating and harvesting, and to sell cannabis. As such, the Notice constitutes a partial suspension of the Company's licence for standard cultivation and a full suspension of its licences for standard processing, medical sales, cannabis drugs and research issued under the Cannabis regulations. As a result, the EMERALD trial will proceed with another licensed provider of cannabis-based medicine extract.

    Conflict of Interest:
    None declared.
  • Published on:
    Emerald trial disclaimer
    • Berzenn Urbi, Researcher/Research Coordinator Gold Coast University Hospital

    This response letter is to include the below disclaimer in the published EMERALD protocol due to the licence suspension of CannTrust Inc. (the study drug manufacturer).

    CORRECTION/DISCLAIMER. As of the date of publication of the 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 (the “Study”), CannTrust Inc. (“CannTrust”) had received a Notice of Licence Suspension pursuant to the Cannabis Act (Canada). The Notice states that Health Canada has suspended CannTrust's authority to produce cannabis, other than cultivating and harvesting, and to sell cannabis. As such, the Notice constitutes a partial suspension of the Company's licence for standard cultivation and a full suspension of its licences for standard processing, medical sales, cannabis drugs and research issued under the Cannabis regulations. During the suspension, CannTrust may not propagate new lots or batches of cannabis or engage in the sale or distribution of cannabis, including the distribution of cannabis referred to in the Study. The Notice states that Health Canada will reinstate CannTrust's licences under section 64(4) of the Cannabis Act if the reasons for the suspension no longer exist or if CannTrust demonstrates that the suspension was unfounded and CannTrust is currently taking steps to ha...

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    Conflict of Interest:
    None declared.