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

Phase 2

Terminated

• Conditions: Insomnia
• Interventions: Drug: CHI-921; Drug: Placebo

• Registration Number: NCT03984604
• Lead Sponsor: Canopy Growth Corporation

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2019-03-21
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-13
• Status Verified: 2019-08
• Primary Completion: 2020-06-17
• Study Completion: 2020-06-17
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHI-921	CHI-921	During the double-blind treatment period (9 weeks), subjects will take 0.5 mL of their randomized treatment (CHI-921) for 3 weeks, followed by another 3 weeks of treatment at 1.0 mL for and another 3 weeks of treatment at 2.0 mL.
Placebo	Placebo	During the double-blind treatment period (9 weeks), subjects will take 0.5 mL of their randomized treatment (placebo) for 3 weeks, followed by another 3 weeks of placebo treatment at 1.0 mL for and another 3 weeks of placebo treatment at 2.0 mL.

Primary Outcome Measures

Name	Time	Method
Change from baseline of PSG latency to persistent sleep	after 3 weeks per treatment dose with CHI-921 compared to placebo
Change from baseline of PSG wake after sleep onset (WASO)	after 3 weeks per treatment dose with CHI-921 compared to placebo

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63	Standard 8 question index
Rey Auditory Verbal Learning Test	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	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
Change from baseline of patient-reported mean sleep latency (subjective sleep latency).	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)	after 3 weeks of treatment
Change from baseline of patient-reported mean wake after sleep onset (subjective WASO)	after 3 weeks of treatment
Patient Global Impression of change (PGI-c)	Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63	Standard 7 question index
Clinical Global Impression of change (CGI-c)	Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63	Standard 7 question index
Insomnia Severity Index (ISI)	Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63	Standard 7 question index
Pittsburgh Sleep Quality Index (PSQI)	Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63	Standard 10 question index

Trial Locations

Locations (1)

Algorithme Pharma Inc.; 🇨🇦 Montréal, Quebec, Canada