Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000464763
Ethics application status
Approved
Date submitted
10/02/2022
Date registered
24/03/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
24/03/2022
Date results information initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 306192 0
CANN-AU-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild sleep disturbance 325131 0
Condition category
Condition code
Mental Health 322538 322538 0 0
Other mental health disorders
Neurological 323060 323060 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322779 0
Treatment: Drugs
Comparator / control treatment
Placebo will be identical in appearance to Satipharm CBD capsules and will contain excipients such as Gelatine (bovine), water and E141 (copper chlorophyllin) but will contain no active drug substance.
Control group
Placebo

Outcomes
Primary outcome [1] 330350 0
To compare the efficacy of a single dose of Satipharm CBD capsules vs placebo on sleep disturbances utilising ISI questionnaire
Timepoint [1] 330350 0
Sleep disturbance assessed by ISI questionnaire score at Day 15 or Day 31 from baseline,
Primary outcome [2] 330824 0
To compare the efficacy of a single dose of Satipharm CBD capsules vs placebo on sleep disturbances utilising PROMIS Sleep disturbance questionnaire.
Timepoint [2] 330824 0
Sleep disturbance assessed by PROMIS sleep disturbance questionnaire score at Day 8, Day 15, Day 22 or Day 31 from baseline.
Secondary outcome [1] 405914 0
To assess the safety and tolerability of single daily oral doses of Satipharm CBD capsules
administered to study subjects over a 30-day period compared to placebo
Timepoint [1] 405914 0
Safety endpoints include evaluation of the following safety parameters:
• Incidence, severity and relationship of AEs (including withdrawals due to safety or
tolerability reasons). Timepoints: Day 1, Day 2, Day 8, Day 15, Day 22, Day 31 (clinic visit), Day 34, Day 37 (EOS)/ or ETV (clinic visit)
• Change from baseline in vital signs. Blood pressure and heart rate is assessed using a sphygmomanometer and body temperature by thermometer. Timepoints: Screening, Day 31 (clinic visit), Day 37 (EOS)/ or ETV (clinic visit)
• Change from baseline in clinical laboratory (haematology and serum chemistry) parameters. Timepoints: Screening, Day 31 (clinic visit), Day 37 (EOS)/ or ETV (clinic visit) - if required

Safety and tolerability will be determined by evaluating physical examination findings, vital signs, clinical laboratory parameters, and AEs.
Secondary outcome [2] 405915 0
To compare the efficacy of different dose levels of Satipharm CBD capsules vs placebo on sleep disturbances
Timepoint [2] 405915 0
Sleep diary data - Participants will be instructed to fill out the diary each morning starting on the morning of Day -2 until Day 31 upon waking to record the previous night’s sleep
Secondary outcome [3] 405916 0
To compare the efficacy of Satipharm CBD capsules vs placebo on patient quality of life utilising SF-36 questionnaire
Timepoint [3] 405916 0
QoL SF-36 stress scores will be measured at baseline on Day-3 and again following dosing with study drug on Day 15 and Day 31.
.
Secondary outcome [4] 405920 0
Exploratory Objective: To compare the efficacy of Satipharm CBD capsules vs placebo on stress levels
Timepoint [4] 405920 0
Perceived stress score (PSS) questionnaire - PSS scores will be established at baseline (day
-3) and following dosing with study drug at weekly intervals (Days 8, 15, 22) and finally at the end of the treatment period on Day 31.
Secondary outcome [5] 406010 0
Exploratory Objective: : To compare the efficacy of Satipharm CBD capsules vs placebo on pain levels
Timepoint [5] 406010 0
McGill SF pain questionnaire - The SF-MPQ will be evaluated at baseline (Day -3) and again at the end of the study treatment period on Day 31.
Secondary outcome [6] 407733 0
To compare the efficacy of Satipharm CBD capsules vs placebo on patient quality of life utilising patient perception of improvement (PPI).
Timepoint [6] 407733 0
PPI will be assessed on Day 15 and Day31

Eligibility
Key inclusion criteria
1. 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.
2. Male or female, greater or equal to 18 or less than or equal to 75 years of age at the time of screening.
3. Body mass index (BMI) less than or equal to 35.0 kg/m2 at screening.
4. 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
5. Participants must agree to not change current diet or exercise or use other supplements for sleep disturbance for the study period
6. Evidence of adequate hepatic function at screening as defined by AST and ALT lesser than or equal to 2.5 × ULN
7. 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.
8. 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.
9. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of significant cardiac disease
2. Any current unstable or serious illness or malignancy
3. Positive test result for COVID-19 at screening
4. Positive drugs of abuse test result at screening
5. Previous use of medicinal cannabis
6. Currently diagnosed with a mood disorder such as depression or bipolar disorder or neurological disorder associated with insomnia
7. 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
8. Diagnosed with sleep apnoea or refractory insomnia (defined as failure of 2 or more sleep medications to improve insomnia symptoms)
9. 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])
10. Caffeine consumption greater than 400 mg/day (equivalent to 4 cups of coffee or 8 cups of black tea)
11. Major surgery within 28 days of study drug administration on Day 1, or minor surgical procedures within 7 days of Day 1
12. For women of childbearing potential (WOCBP), a positive serum pregnancy test.
13. Pregnant or breast-feeding (or planning to breastfeed) while on study through 3 months after the last dose of study drug.
14. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.
15. 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.
16. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants to be dosed will be assigned a randomisation number in accordance with the randomisation schedule. Each participant will be assigned to receive either Satipharm CBD capsules at one of 3 dose levels or placebo. The randomization schedules will be prepared by unblinded statisticians and will be maintained under controlled access. As the study is double-blinded, sealed participant-specific code break envelopes will also be produced by the unblinded statisticians and will be retained at the clinical facility in a secure, accessible location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation to Satipharm CBD capsules or placebo will be performed using a block randomisation algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The total sample size for this study is 212 (53/treatment arm) which has been calculated based on 90% power to detect a 2-point change in ISI score or a 3-point change on the PROMIS sleep disturbance score (the primary outcome measures) on Day 15 or Day 31 at a significance level of P lesser than 0.05. The number of subjects includes a buffer of 20% to account for attrition. Recruitment will be stopped when the sample size for all the treatment groups reach 53 subjects. Blinded interim analysis will be conducted to re-evaluate the sample size and possibly increase the sample size.

For the purposes of analysis, the following analysis sets are defined:
- Full analyses set (FAS) - The FAS will include all participants who enrolled into the study and will be analyzed according to the randomized treatment, regardless of which treatment the participants received. This population will be used for all summaries of baseline and demographic data. In addition, all listings will be produced for the FAS.
- Safety Population - The Safety Population will include all randomized participants who are exposed to investigational product. Participants will be analyzed according to the intervention they actually received. The Safety Population will be used for the summaries of all safety data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2022
Actual
30/03/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
14/10/2022
Date of last data collection
Anticipated
30/10/2022
Actual
11/11/2022
Sample size
Target
212
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 21640 0
Paratus Clinical Research - Brisbane - Albion
Recruitment hospital [2] 21641 0
Paratus Clinical Pty Ltd Blacktown Trial Clinic - Blacktown
Recruitment hospital [3] 21643 0
Paratus Clinical Pty Ltd Kanwal Trial Clinic - Kanwal
Recruitment hospital [4] 21664 0
Captain Stirling Medical Centre - Nedlands
Recruitment hospital [5] 21937 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [6] 21938 0
Paratus Clinical Research - Ochre Health Medical Centre Bruce - Bruce
Recruitment postcode(s) [1] 36571 0
2148 - Blacktown
Recruitment postcode(s) [2] 36573 0
2259 - Kanwal
Recruitment postcode(s) [3] 37018 0
2617 - Bruce
Recruitment postcode(s) [4] 36570 0
4010 - Albion
Recruitment postcode(s) [5] 37022 0
5000 - Adelaide
Recruitment postcode(s) [6] 36709 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 24880 0
New Zealand
State/province [1] 24880 0
Lakeland Clinical Trials Rotorua – Rotorua 3010
Country [2] 24881 0
New Zealand
State/province [2] 24881 0
Southern Clinical Trails Christchurch – Christchurch 8013

Funding & Sponsors
Funding source category [1] 310532 0
Commercial sector/Industry
Name [1] 310532 0
CANN Group Limited
Country [1] 310532 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CANN Group Limited
Address
4 Research Avenue, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 311705 0
Commercial sector/Industry
Name [1] 311705 0
Avance Clinical Pty Ltd
Address [1] 311705 0
Avance Clinical Pty Ltd
Level 1, 2 Ann Nelson Drive
Thebarton, SA 5031, Australia
Country [1] 311705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310155 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 310155 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 310155 0
Australia
Date submitted for ethics approval [1] 310155 0
06/12/2021
Approval date [1] 310155 0
15/02/2022
Ethics approval number [1] 310155 0
2021-12-1430
Ethics committee name [2] 311237 0
Southern Health and Disability Ethics Committee
Ethics committee address [2] 311237 0
133 Molesworth Street, Thorndon, Wellington 6011
Ethics committee country [2] 311237 0
New Zealand
Date submitted for ethics approval [2] 311237 0
02/06/2022
Approval date [2] 311237 0
Ethics approval number [2] 311237 0
2022 - 12896

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116678 0
Dr Sheetal Bull
Address 116678 0
Paratus Clinical Research Brisbane
Albion Health Suites, 6 Crosby Road
Albion Qld 4010
Country 116678 0
Australia
Phone 116678 0
+61 1300742326
Fax 116678 0
Email 116678 0
sheetal.bull@paratusclinical.com
Contact person for public queries
Name 116679 0
Ms Jay Exenberger
Address 116679 0
Level 1, 2 Ann Nelson Drive, Thebarton
South Australia 5031
Country 116679 0
Australia
Phone 116679 0
+61 451 133 823
Fax 116679 0
Email 116679 0
Jay.Exenberger@avancecro.com
Contact person for scientific queries
Name 116680 0
Ms Jay Exenberger
Address 116680 0
Level 1, 2 Ann Nelson Drive, Thebarton
South Australia 5031
Country 116680 0
Australia
Phone 116680 0
+61 451 133 823
Fax 116680 0
Email 116680 0
Jay.Exenberger@avancecro.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy and Intellectual property considerations


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.