InsomniaPhase 2NCT03984604
Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
A Phase 2 study testing CHI-921 in people with Insomnia, run by Canopy Growth Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Insomnia
- What is being tested?
- CHI-921
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 21 Mar 2019to 17 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- CHI-921, Placebo
- Keywords
- sleep, cannabis, primary insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHI-921Drug
a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form
PlaceboDrug
Placebo is a vehicle oil will match CHI-921
| Study group | Role | What they receive |
|---|---|---|
| CHI-921 | Active comparator | 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. Receives: Drug: CHI-921 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of PSG latency to persistent sleep
Measured: after 3 weeks per treatment dose with CHI-921 compared to placebo
Change from baseline of PSG wake after sleep onset (WASO)
Measured: after 3 weeks per treatment dose with CHI-921 compared to placebo
Secondary outcomes (10)
Change from baseline of patient-reported mean sleep latency (subjective sleep latency).
Measured: after 3 weeks of treatment
Change from baseline of patient-reported mean wake after sleep onset (subjective WASO)
Measured: 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)
Measured: after 3 weeks of treatment
Patient Global Impression of change (PGI-c)
Standard 7 question index
Measured: 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
Measured: 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
Measured: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Pittsburgh Sleep Quality Index (PSQI)
Standard 10 question index
Measured: 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
Measured: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Rey Auditory Verbal Learning Test
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start21 Mar 2019
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Galenova Inc, Algorithme Pharma Inc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Sponsor
- Investigators
- Dr M Ware, MD, Study director, Canopy Growth Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984604
- Sponsor's protocol ID
- H2017-01
- Status last verified
- Aug 2019
- First submitted
- 11 Jun 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03984604
- Acronym / sponsor ID
- H2017-01
- Conditions
- Insomnia
- Keywords
- sleep, cannabis, primary insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Galenova Inc, Algorithme Pharma Inc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHI-921 | Active comparator | Drug: CHI-921During 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 comparator | Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
- Willing to comply with all study requirements and procedures for the duration of the clinical study
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHI-921a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form | Drug | CHI-921 |
| PlaceboPlacebo is a vehicle oil will match CHI-921 | Drug | Placebo |
Primary outcome
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
10 secondary outcomes
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)
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)
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Insomnia Severity Index (ISI)
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63
Epworth Sleepiness Scale (ESS)
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
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr M Ware, MD study director
Canopy Growth Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHI-921 in people with Insomnia, run by Canopy Growth Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of PSG latency to persistent sleep (time frame: after 3 weeks per treatment dose with CHI-921 compared to placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.