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

NCT03984604 | Terminated Phase 2

• 1 other identifier: H2017-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

sleep; cannabis; primary insomnia

Outcome Measures

Primary Outcomes (2)

• Change from baseline of PSG latency to persistent sleep

  after 3 weeks per treatment dose with CHI-921 compared to placebo

• Change from baseline of PSG wake after sleep onset (WASO)

  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).

  after 3 weeks of treatment

• Change from baseline of patient-reported mean wake after sleep onset (subjective WASO)

  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)

  after 3 weeks of treatment

• Patient Global Impression of change (PGI-c)

  Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63

• Clinical Global Impression of change (CGI-c)

  Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

CHI-921 DRUG

a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form

CHI-921

Placebo DRUG

Placebo is a vehicle oil will match CHI-921

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Body mass index \> 32 calculated from patient's height (m) and weight (kg); weight (kg)/square height (m²)
• 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
• Women who are pregnant, are planning to become pregnant, or are breastfeeding

Sponsors & Collaborators

• Canopy Growth Corporation: lead
• Galenova Inc: collaborator
• Algorithme Pharma Inc: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

Algorithme Pharma Inc.

Montreal, Quebec, H3B 1P5, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Marijuana Abuse

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Dr M Ware, MD

  Canopy Growth Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 13, 2019
• Study Start: March 21, 2019
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: October 5, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)