- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984604
Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
September 30, 2020 updated by: Canopy Growth Corporation
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
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.
Study Overview
Detailed Description
The study is designed to:
- 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.
- To evaluate the effects of CHI-921 compared to placebo on PSG sleep architecture.
- To evaluate the effects of CHI-921 compared to placebo on Patient Global Impression of change.
- 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.
- To assess the effect on sleep of abruptly discontinuing CHI-921 compared to placebo (during run-out period).
- To evaluate the clinical safety and tolerability of CHI-921 compared to placebo.
- Evaluation of the accuracy of sleep data obtained by actigraphy as compared to traditional PSG.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Montréal, Quebec, Canada, H3B 1P5
- Algorithme Pharma Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Male or female subjects 25 to 70 years of age, inclusive
- Willing and able to give informed consent for study participation
- Each patient must have insomnia disorder based on criteria (ICSD-3 or DSM-5) with predominant complaints of difficulty in initiating or maintaining sleep for at least three months preceding the study visit and having clinically significant distress or impairment in social occupational or other important areas of functioning
Normal vital signs as follows:
- Sitting systolic blood pressure (SBP) between 90 and 140 mmHg, inclusive
- Sitting diastolic blood pressure (DBP) between 55 and 90 mmHg, inclusive
- Pulse rate between 50 and 100 bpm inclusive
- Willing to comply with all study requirements and procedures for the duration of the clinical study
Willing to comply with the study restrictions including:
- Adherence to concomitant drug washout requirements, as applicable, for the duration of the clinical study
- Willing to abstain from alcohol for the duration of the clinical study
- Willing to abstain from caffeine 10 hours before each recording
- If a smoker, willing to abstain from smoking at night from approximately 10 pm to 8 am for the duration of the clinical study
Female subjects who:
- Are postmenopausal, with amenorrhea for at least 1 year before the screening visit,
- Are surgically sterile, OR
- If of childbearing potential agree to practice effective double barrier methods of contraception, from the time of the signing of informed consent through the last dose of study drug and for 30 days after dosing stops (1 ovulatory cycle), or agree to completely abstain from intercourse
- Males with female partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops.
- Self-reported bedtime between 9 pm and midnight on 4-7 nights per week
Based on the PSG recordings during the screening nights (V2; SN1 and SN2), one of the following criteria must be present:
- Mean WASO calculated on SN1 and SN2 > 30 min or
- Mean LPS: calculated on SN1 and SN2 > 30 min
Exclusion Criteria
- Body mass index > 32 calculated from patient's height (m) and weight (kg); weight (kg)/square height (m²)
- Presence of a sleep disorder (for sleep apnea syndrome, an apnea-hypopnea index > 15 per hour of sleep on the first screening night will be used as an exclusion criterion; for periodic limb movement disorder, an index of periodic limb movements during sleep associated with an arousal > 10 per hour of sleep on the first screening night will be used as an exclusion criterion)
- Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions)
- Serious head injury or stroke within the past year
- Any evidence of psychiatric disorder (including Beck Depression Inventory [BDI] ≥ 20) and/or history of psychosis excluding insomnia
- Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug, or may affect patient safety
- Clinically significant and abnormal electrocardiogram (ECG; including QTc ≥ 450 ms for males, 460 ms for females) or patients with a history of cardiovascular disease including poorly controlled hypertension, ischaemic heart disease, arrhythmia, or severe heart failure
- Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene), at screening
- Use of any substance with psychotropic effects or properties known to affect sleep/wake, including neuroleptics, morphine/opioid derivatives, antihistamines, stimulants antidepressants, clonidine, within one week or five half-lives (whichever is longer) prior to screening
- Use of any over-the-counter sleep medications including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St John's Wort (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root), and hemp within 1 week or 5 half-lives (whichever is longer) prior to screening
- Consumption of xanthine-containing beverages (i.e., tea, coffee, or cola) of more than 5 cups or glasses per day
- Participation in any other trial within 30 days before the screening visit
- Night shift workers (during the 12 months prior to the study and during the study)
- Individuals who nap 3 or more times per week over the preceding month
- Individuals having to travel across more than 3 time zones in the month prior to screening or individuals who plan on travelling outside of their country of residence at any time during the study
- Other exclusion criteria based on adverse events (AE) or serious adverse events (SAE) reported in the Investigator Brochure
- Women who are pregnant, are planning to become pregnant, or are breastfeeding
- Individuals may be excluded from participating in the study based on the investigator's professional judgement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form
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Placebo Comparator: 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.
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Placebo is a vehicle oil will match CHI-921
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline of PSG latency to persistent sleep
Time Frame: after 3 weeks per treatment dose with CHI-921 compared to placebo
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after 3 weeks per treatment dose with CHI-921 compared to placebo
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Change from baseline of PSG wake after sleep onset (WASO)
Time Frame: after 3 weeks per treatment dose with CHI-921 compared to placebo
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after 3 weeks per treatment dose with CHI-921 compared to placebo
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of patient-reported mean sleep latency (subjective sleep latency).
Time Frame: after 3 weeks of treatment
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after 3 weeks of treatment
|
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Change from baseline of patient-reported mean wake after sleep onset (subjective WASO)
Time Frame: after 3 weeks of treatment
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after 3 weeks of treatment
|
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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
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after 3 weeks of treatment
|
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Patient Global Impression of change (PGI-c)
Time Frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Standard 7 question index
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Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Clinical Global Impression of change (CGI-c)
Time Frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Standard 7 question index
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Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Insomnia Severity Index (ISI)
Time Frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Standard 7 question index
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Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Standard 10 question index
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Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Epworth Sleepiness Scale (ESS)
Time Frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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Standard 8 question index
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Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
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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
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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
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Dr M Ware, MD, Canopy Growth Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2019
Primary Completion (Actual)
June 17, 2020
Study Completion (Actual)
June 17, 2020
Study Registration Dates
First Submitted
June 11, 2019
First Submitted That Met QC Criteria
June 11, 2019
First Posted (Actual)
June 13, 2019
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2017-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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