Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 6:49 PM
Study NCT ID:
NCT03984604
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
Sponsor:
Canopy Growth Corporation
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Dose-Titration Study on the Efficacy and Safety of CHI-921 on Sleep Initiation and Maintenance in Subjects With Insomnia
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: