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CHI-921 for Sleep Initiation and Maintenance in Insomnia
NCT03984604Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2019
- Primary completion
- Jun 2020
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- Insomnia
01
Overview
Phase 2, randomised, double-blind trial in Insomnia comparing CHI-921 with Placebo (2 arms). Primary endpoints: Change from baseline of PSG latency to persistent sleep and Change from baseline of PSG wake after sleep onset. Started Mar 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CHI-921
Cannabis extract titration: 0.5mL -> 1.0mL -> 2.0mL
Placebo
Placebo oil titration matching active arm
03
Who it enrols
Adults aged 25-70 with insomnia disorder (>3 months) and objective sleep disturbance on PSG (WASO > 30 min or LPS > 30 min), excluding those with BMI > 32, sleep apnea, other sleep disorders, psychiatric disorders, or recent use of sleep medications.
04
Endpoints
Primary
Change from baseline of PSG latency to persistent sleep
Change from baseline of PSG wake after sleep onset
Secondary
Change from baseline of patient-reported mean sleep latency
Change from baseline of patient-reported mean wake after sleep onset
Change from baseline on PSG sleep architecture
Patient Global Impression of Change
Clinical Global Impression of Change
Insomnia Severity Index
Pittsburgh Sleep Quality Index
Epworth Sleepiness Scale
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