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Investigation of the Efficacy and Safety of CHI-921 in Insomnia.

NCT03984604 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-10-05

No results posted yet for this study

Summary

Insomnia is a disorder where people are having trouble sleeping and can include difficulty falling asleep, staying asleep and waking up too early, as well as having unrefreshing sleep. CHI-921 is a cannabis extract in sunflower oil produced as a treatment for insomnia. This trial is designed to evaluate the efficacy and safety of CHI-921 on people with insomnia.

Conditions

Interventions

DRUG

CHI-921

a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form

DRUG

Placebo

Placebo is a vehicle oil will match CHI-921

Sponsors & Collaborators

  • Galenova Inc

    collaborator OTHER

  • Algorithme Pharma Inc

    collaborator INDUSTRY

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • Canopy Growth Corporation

    lead INDUSTRY

Principal Investigators

  • Dr M Ware, MD · Canopy Growth Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2020-06-17
Completion
2020-06-17

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT03984604 on ClinicalTrials.gov