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

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ClinicalTrials.gov Identifier: NCT03984604
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
Galenova Inc
Algorithme Pharma Inc
Hopital du Sacre-Coeur de Montreal
McGill University Health Centre/Research Institute of the McGill University Health Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Canopy Health Innovations

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE March 21, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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 WASO [ Time Frame: after 3 weeks per treatment dose with CHI-921 compared to placebo ]
Change History Complete list of historical versions of study NCT03984604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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 ]
    Standard 7 question index
  • 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 ]
    Standard 7 question index
  • Insomnia Severity Index (ISI) [ Time Frame: 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) [ Time Frame: Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63 ]
    Standard 10 question index
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 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 [ 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change from baseline of patient-reported mean sleep latency and patient-reported mean wake after sleep onset (subjective sleep latency and 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/Night1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63 ]
  • Clinician Global Impression of change (CGI-c) [ Time Frame: Visit 2/Night1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: CHI-921
    a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form
  • Drug: Placebo
    Placebo is a vehicle oil will match CHI-921
Study Arms  ICMJE
  • 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.
    Intervention: Drug: CHI-921
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Male or female subjects 25 to 70 years of age, inclusive
  2. Willing and able to give informed consent for study participation
  3. 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
  4. 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
  5. Willing to comply with all study requirements and procedures for the duration of the clinical study
  6. 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
  7. 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.
  8. Self-reported bedtime between 9 pm and midnight on 4-7 nights per week
  9. Based on the PSG recordings during the screening nights (V2; SN1 and SN2), one of the following criteria must be present:

    1. Mean WASO calculated on SN1 and SN2 > 30 min or
    2. Mean LPS: calculated on SN1 and SN2 > 30 min

Exclusion Criteria

  1. Body mass index > 32 calculated from patient's height (m) and weight (kg); weight (kg)/square height (m²)
  2. 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)
  3. Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions)
  4. Serious head injury or stroke within the past year
  5. Any evidence of psychiatric disorder (including Beck Depression Inventory [BDI] ≥ 20) and/or history of psychosis excluding insomnia
  6. 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
  7. 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
  8. Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene), at screening
  9. 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
  10. 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
  11. Consumption of xanthine-containing beverages (i.e., tea, coffee, or cola) of more than 5 cups or glasses per day
  12. Participation in any other trial within 30 days before the screening visit
  13. Night shift workers (during the 12 months prior to the study and during the study)
  14. Individuals who nap 3 or more times per week over the preceding month
  15. 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
  16. Other exclusion criteria based on adverse events (AE) or serious adverse events (SAE) reported in the Investigator Brochure
  17. Women who are pregnant, are planning to become pregnant, or are breastfeeding
  18. Individuals may be excluded from participating in the study based on the investigator's professional judgement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lia Casaca, MA 647-930-2888 ext 700 lia.casaca@canopygrowth.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984604
Other Study ID Numbers  ICMJE H2017-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canopy Health Innovations
Study Sponsor  ICMJE Canopy Health Innovations
Collaborators  ICMJE
  • Galenova Inc
  • Algorithme Pharma Inc
  • Hopital du Sacre-Coeur de Montreal
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Centre hospitalier de l'Université de Montréal (CHUM)
Investigators  ICMJE
Study Director: Dr M Ware, MD Canopy Health Innovations
PRS Account Canopy Health Innovations
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP