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.
The study is designed to: 1. Evaluate the patient-reported sleep latency and patient-reported wake after sleep onset after 3 weeks per treatment dose with CHI-921 compared to placebo. 2. To evaluate the effects of CHI-921 compared to placebo on PSG sleep architecture. 3. To evaluate the effects of CHI-921 compared to placebo on Patient Global Impression of change. 4. To evaluate the daytime residual effects that may be associated with CHI-921 as compared to placebo during the double-blind treatment period using patient's morning and evening questionnaire, Clinical Global Impression of change, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale as well as the Rey Auditory Verbal Learning Test and Digit Symbol Substitution psychometric tests. 5. To assess the effect on sleep of abruptly discontinuing CHI-921 compared to placebo (during run-out period). 6. To evaluate the clinical safety and tolerability of CHI-921 compared to placebo. 7. Evaluation of the accuracy of sleep data obtained by actigraphy as compared to traditional PSG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Algorithme Pharma Inc.
Montreal, Quebec, Canada
Change from baseline of PSG latency to persistent sleep
Time frame: after 3 weeks per treatment dose with CHI-921 compared to placebo
Change from baseline of PSG wake after sleep onset (WASO)
Time frame: after 3 weeks per treatment dose with CHI-921 compared to placebo
Change from baseline of patient-reported mean sleep latency (subjective sleep latency).
Time frame: after 3 weeks of treatment
Change from baseline of patient-reported mean wake after sleep onset (subjective WASO)
Time frame: after 3 weeks of treatment
Change from baseline on PSG sleep architecture: percentage of total sleep spent in each sleep stage (N1, N2, N3 and rapid eye movement [REM] sleep)
Time frame: after 3 weeks of treatment
Patient Global Impression of change (PGI-c)
Standard 7 question index
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Clinical Global Impression of change (CGI-c)
Standard 7 question index
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Insomnia Severity Index (ISI)
Standard 7 question index
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Pittsburgh Sleep Quality Index (PSQI)
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Standard 10 question index
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Epworth Sleepiness Scale (ESS)
Standard 8 question index
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Rey Auditory Verbal Learning Test
Time frame: Visit 2/Screening Night 1 and 2, Visit 3/ Night 1, Visit 4/Night 21 and 22, Visit 5/Night 42 and 43, Visit 6/Night 63
Digit Symbol Substitution Test
Time frame: Visit 2/Screening Night 1 and 2, Visit 3/ Night 1, Visit 4/Night 21 and 22, Visit 5/Night 42 and 43, Visit 6/Night 63