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A study to evaluate the safety and efficacy of sublingual cannabinoid based medicineextract compared with placebo for the treatment of Insomnia

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Trial Profile

A study to evaluate the safety and efficacy of sublingual cannabinoid based medicineextract compared with placebo for the treatment of Insomnia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 28 Mar 2022

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At a glance

  • Drugs Nabiximols (Primary)
  • Indications Insomnia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Zelda Therapeutics; Zelira Therapeutics

    • Most Recent Events

    • 07 Apr 2020 According to a Zelira Therapeutics media release, results from this trial open prospects to launch and distribute this product in global markets including the USA in the second half of 2020.
    • 18 Feb 2020 According to a Zelira Therapeutics media release, A final report from the clinical study including an analysis of a comprehensive suite of secondary endpoints will be provided by end of March 2020. These results will inform the design of any future clinical studies.
    • 18 Feb 2020 Primary endpoint has been met. (safety and efficacy as evaluated by adverse event reporting and insomnia symptoms measured by the Insomnia Severity Index questionnaire.), according to a Zelira Therapeutics media release.

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