A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of CBD Capsules in Adults with Sleep Disturbance
CANN Group Limited
212 participants
Mar 30, 2022
Interventional
Conditions
Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of CBD capsules in adults with sleep disturbance. Adults will be screened for study eligibility by attending the clinic between Day -28 and Day -4. Study eligibility will be confirmed at the clinic on Day -3 and baseline measures will be conducted at home between Days -3 to Day 1 with Day 1 being the first day of study drug administration. Participants will be required to attend the study clinic at screening, on Day 31, and Day 37 (EOS) or ETV. There will be no clinical confinement period in this study and all clinical assessments will be performed as outpatient visits or telehealth consultations. The study will evaluate 3 dose levels of the investigational product, Satipharm CBD capsules or placebo in 4 parallel treatment arms of 53 participants per arm. Participants will be enrolled across 4 parallel treatment arms to receive daily doses of Satipharm CBD or placebo for a period of 30 days. Treatment Arm 1 : 0mg (placebo), Treatment Arm 2: 25 mg, treatment arm 3: 50 mg, treatment arm 4:100 mg. A single daily dose of Satipharm CBD capsules or placebo (2 capsules/dose) will be administered from Day 1 to Day 30 whereby each participant will receive a total of 30 doses with an evening meal. Study drug will be self-administered on a daily basis from Day 1 through to Day 30. Outpatient clinic visits are scheduled for Days 31 (the day following the last dose of study drug), and again on Day 37 which is the end of study (EOS) visit.
Eligibility
Inclusion Criteria15
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Male or female, greater or equal to 18 or less than or equal to 75 years of age at the time of screening.
- Body mass index (BMI) less than or equal to 35.0 kg/m2 at screening.
- Are experiencing a disturbed sleeping pattern (ISI score greater than or equal to 10) at the time of screening which has been present for a duration of at least 1 month and has any of the following:
- a. Difficulty falling asleep
- b. Difficulty maintaining sleep
- c. Waking earlier than desired
- d. Current dissatisfaction with sleep patterns
- Participants must agree to not change current diet or exercise or use other supplements for sleep disturbance for the study period
- Evidence of adequate hepatic function at screening as defined by AST and ALT lesser than or equal to 2.5 × ULN
- Female participants:
- a. Must be of non-childbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause OR
- b. If of childbearing potential, must agree not to attempt to become pregnant, must not donate ova and must agree to use an acceptable form of contraception (Appendix 5) from signing the consent form until at least 3 months after the last dose of study drug.
- Male participants must agree not to donate sperm and must agree to use an acceptable contraceptive method in addition to having the female partner use an acceptable contraceptive method from signing the consent form until at least 3 months after the last dose of study drug.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
Exclusion Criteria16
- History of significant cardiac disease
- Any current unstable or serious illness or malignancy
- Positive test result for COVID-19 at screening
- Positive drugs of abuse test result at screening
- Previous use of medicinal cannabis
- Currently diagnosed with a mood disorder such as depression or bipolar disorder or neurological disorder associated with insomnia
- Received a prescribed or over the counter sleep medication within 4 weeks or 5 half-lives (whichever is shorter) prior to screening or other form of sleep aid
- Diagnosed with sleep apnoea or refractory insomnia (defined as failure of 2 or more sleep medications to improve insomnia symptoms)
- Current consumption of greater than 14 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], 30 mL spirit [40% Alc/Vol])
- Caffeine consumption greater than 400 mg/day (equivalent to 4 cups of coffee or 8 cups of black tea)
- Major surgery within 28 days of study drug administration on Day 1, or minor surgical procedures within 7 days of Day 1
- For women of childbearing potential (WOCBP), a positive serum pregnancy test.
- Pregnant or breast-feeding (or planning to breastfeed) while on study through 3 months after the last dose of study drug.
- Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.
- Known substance abuse or medical, psychological, or social conditions that, in the opinion of the investigator (or delegate), may interfere with the participants inclusion in the clinical study or evaluation of the clinical study results.
- Any other condition or prior therapy that in the opinion of the investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
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Interventions
Participants will be enrolled across 4 parallel treatment arms to receive daily oral doses of Satipharm CBD or placebo for a period of 30 days. Treatment Arm 1 : 0 mg (placebo), Treatment Arm 2: 25 mg, treatment arm 3: 50 mg, treatment arm 4:100 mg. A single daily dose of Satipharm CBD capsules or placebo (2 capsules/dose) will be administered from Day 1 to Day 30 (each participant will receive a total of 30 doses) with an evening meal. Study drug will be self-administered on a daily basis from Day 1 through to Day 30. Outpatient clinic visits are scheduled for Days 31 (the day following the last dose of study drug), and again on Day 37 (± 2 days) which is the end of study (EOS) visit. Adherence to the intervention will be done via drug accountability and the participants completion of a daily diary.
Locations(8)
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ACTRN12622000464763