Autism Spectrum Disorder
Conditions
Keywords
Cannabidiol oral solution, CBD-OS, GWP42003-P, Children, Adolescents
Brief summary
This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).
Interventions
DRUGGWP42003-P
GWP42003-P oral solution (100 milligrams per milliliter \[mg/mL\] cannabidiol \[CBD\] in sesame oil with anhydrous ethanol, ethanol \[10% v/v\] sweetener \[sucralose\], and strawberry flavoring), administered twice a day (morning and evening)
DRUGPlacebo
Oral placebo to match GWP42003-P oral solution containing sesame oil with anhydrous ethanol, sweetener (sucralose), strawberry flavoring, and beta carotene, administered twice a day (morning and evening)
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participant weight is at least 12 kilograms (kg). * Participants (if possessing adequate understanding, in the investigator's opinion) and their parent(s)/legal representative are willing and able to give informed assent and consent for participation in the trial. * Participant and their caregiver are willing and able (in the investigator's opinion) to comply with all trial requirements. * Participant has a diagnosis of Autism Spectrum Disorder (ASD) as per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ASD, confirmed by Autism Diagnostic Observational Schedule (ADOS-2) criteria (conducted within 2 years at the trial site or at screening by a qualified assessor). Note: During special circumstances (e.g., COVID-19 pandemic) where the ADOS-2 cannot be performed due to site restrictions (e.g., mandatory use of face masks) and an ADOS- 2 conducted within 2 years at the trial site by a qualified assessor is not available, eligibility can be confirmed using: 1) an ADOS-2 performed within 2 years by a qualified assessor (external to the site); 2) if 1) is not available, eligibility may be confirmed using the Autism Diagnostic Interview, Revised (ADI-R) at screening. * Clinical Global Impressions - Improvement Scale (CGI-S) ≥ 4 (moderately ill) at screening and randomization. * Intelligence quotient (IQ) ≥ 70 at screening, or measured within 1 year of screening, using Wechsler Abbreviated Scale of Intelligence Scale Second Edition (WASI-II). * All medications or interventions (including psychosocial interventions, dietary supplements, probiotics, speech therapy, etc.) for ASD related symptoms must have been stable for 4 weeks prior to screening and randomization, and the patient/caregiver should be willing to maintain a stable regimen throughout the trial. * Participants must have the ability to swallow the investigational medicinal product (IMP), provided as a liquid solution. * Participant and/or parent(s)/legal representative is willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law. * Participant and/or parent(s)/legal representative is/are willing to allow the participant's primary care practitioner (if they have one) and consultant (if they have one) to be notified of participation in the trial if the primary care practitioner/consultant is different from the investigator.
Exclusion criteria
* Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression (participants with depression in remission may be included) * Has a diagnosis other than ASD that dominates the clinical presentation (e.g., Attention Deficit Hyperactivity Disorder \[ADHD\]) * Has a progressive neurological condition * Seizures in the past 24 weeks * Changes in anticonvulsive therapy within the last 12 weeks * Currently taking more than 2 anti-epileptic drugs (AEDs) * Taking sirolimus, everolimus, temsirolimus, or tacrolimus * Taking clobazam * Taking omeprazole, lansoprazole, tolbutamide, or warfarin * Taking repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz * Currently using or has used recreational or medicinal cannabis, cannabinoid-based medications (including Sativex®, or Epidiolex®) within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial * Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP, such as sesame oil. * Participant has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × upper limit of normal (ULN) or total bilirubin (TBL) \> 2 × ULN. This criterion can only be confirmed once the laboratory results are available; participants enrolled into the trial who are later found to meet this criterion must be screen-failed. * Participant is male and fertile (i.e., after puberty unless permanently sterile by bilateral orchidectomy) unless willing to ensure that they use male contraception (condom) or remain sexually abstinent during the trial and for 12 weeks thereafter. * Participant is female and of childbearing potential (i.e., following menarche and until becoming postmenopausal for ≥ 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that they use a highly effective method of birth control (e.g., hormonal contraception, intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the trial and for 12 weeks thereafter. * Female participant who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial or within 12 weeks thereafter. * Participant has received an IMP within the 12 weeks prior to the screening visit. * Participant had brain surgery or traumatic brain injury within 1 year of screening. * Participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the trial, may influence the result of the trial, or may affect the participant's ability to take part in the trial. * Any abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant if they took part in the trial * Any history of suicidal behavior (lifelong) or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last 4 weeks or at screening or randomization * Participant has donated blood during the past 12 weeks and is unwilling to abstain from donation of blood during the trial. * Participant has any known or suspected history of alcohol or substance abuse or positive drugs of abuse test at screening (not justified by a known concurrent medication). * Participant has previously been randomized into this trial. * Participant has plans to travel outside their country of residence during the trial, unless the participant has confirmation that the IMP is permitted in the destination country/state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | Baseline up to Week 12 | The caregiver-assessed ABC was designed to assess the presence and severity of various problem behaviors commonly observed in individuals diagnosed with intellectual and developmental disability. The checklist contains 5 subscales: Irritability (15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). The total score of all items for each subscale range from 0-45 (irritability), 0-48 (social withdrawal and hyperactivity/noncompliance), 0-21 (stereotypic behavior), and 0-12 (inappropriate speech) where higher scores indicate worse clinical outcome. The change from baseline to Week 4, Week 8, and Week 12 is reported with lower scores indicating better clinical outcome. |
| Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Baseline up to Week 12 | The VABS-3 scales assess what a person does, rather than what he or she can do. The Vineland-3 assesses adaptive behavior in 3 domains: Communication, Daily Living Skills, and Socialization. Each domain is comprised of 3 subdomains: receptive expression and written (communication); personal, domestic and community (daily living skills); Interpersonal relationships, play and leisure and copying skills (socialization). The adaptive behavior composite score is calculated as arithmetic mean of all 3 domain scores. The total score range is 20 to 140, where low scores indicate low (worst) clinical outcome and high scores indicate high (best) clinical outcome. The change from baseline in VABS-3 is being reported with positive values indicating a positive improvement in adaptive behavior. |
| Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Day 85 | The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The clinician is asked: Compared to the patient's condition at admission to the project, how much has the patient changed? This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Higher scores indicate worse clinical outcome. The number of patients in each CGI-I category is reported. |
| Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Baseline up to Week 12 | The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's experience with patients who have the same diagnosis. The clinician is asked: Considering your total clinical experience with this particular population, how ill is the patient at this time? This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Higher scores indicate worse outcome. The change from baseline in CGI-S scores is reported and lower mean scores indicate better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels | Week 9 (end of taper/withdrawal) | — |
| Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels | Week 9 (end of taper/withdrawal) | — |
| Number of Patients With Clinically Significant Vital Sign Values | Post-baseline up to 12 weeks | — |
| Number of Participants Reporting Treatment-emergent Adverse Events | Baseline up to Week 12 | A TEAE is one that started, or worsened in severity or seriousness, following the first dose of IMP. AEs were coded according to the Medical Dictionary for Regulatory Activities v24.0 dictionary. |
| Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | Baseline up to Day 85 post-baseline | — |
| Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Day 92 | C-SSRS rating scale results since last visit is reported. The presence/absence of any suicidal ideation or behavior is scored based on yes/no responses. The overall number of participants reporting suicidal ideation or behavior is being reported. |
| Number of Patients With Clinically Significant Physical Examination Procedure Findings | Baseline up to Day 85 post-baseline | Number of patients with abnormal physical exam findings are reported. |
| Mean Change From Baseline in Hematology Clinical Laboratory Levels | Baseline up to Week 9 (end of taper/withdrawal) | — |
| Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Baseline up to Week 9 (end of taper/withdrawal) | — |
| Mean Change From Baseline in Hemoglobin Levels | Week 9 (end of taper/withdrawal) | — |
Countries
Australia, Canada, Germany, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 191 patients were screened for this study. Of those 191 patients, 103 patients met all inclusion criteria and no exclusion criteria were enrolled in the study and randomized to treatment at 24 centers in the United States, Canada, Spain, United Kingdom, and Australia.
Pre-assignment details
Eligible participants were randomized 7 to 14 days after the screening visit (Visit 1), once all required assessments were completed and laboratory results were reviewed. If required, screening assessments were permitted to be split over 2 visits; however, both visits were conducted within 7- to 14-day window prior to randomization (Visit 2).
Participants by arm
| Arm | Count |
|---|---|
| GWP42003-P Patients who were randomized to 5 mg/kg/day GWP42003-P for 1 week and then 10 mg/kg/day GWP42003-P for 11 weeks. At the end of treatment, participants tapered off the medication over a period of 1 week. | 49 |
| Placebo Patients who were randomized to placebo for 12 weeks. | 54 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | GWP42003-P | Placebo | Total |
|---|---|---|---|
| Aberrant Behavior Checklist Hyperactivity/Noncompliance | 25.2 score on a scale STANDARD_DEVIATION 12.27 | 26.9 score on a scale STANDARD_DEVIATION 9.63 | 26.1 score on a scale STANDARD_DEVIATION 10.93 |
| Aberrant Behavior Checklist Inappropriate Speech | 5.7 score on a scale STANDARD_DEVIATION 3.22 | 5.6 score on a scale STANDARD_DEVIATION 3.08 | 5.6 score on a scale STANDARD_DEVIATION 3.13 |
| Aberrant Behavior Checklist Irritability | 23.2 score on a scale STANDARD_DEVIATION 7.36 | 22.5 score on a scale STANDARD_DEVIATION 8.74 | 22.8 score on a scale STANDARD_DEVIATION 8.09 |
| Aberrant Behavior Checklist Social Withdrawal | 12.6 score on a scale STANDARD_DEVIATION 8.63 | 12.7 score on a scale STANDARD_DEVIATION 9.11 | 12.7 score on a scale STANDARD_DEVIATION 8.85 |
| Aberrant Behavior Checklist Stereotypic Behavior | 6.7 score on a scale STANDARD_DEVIATION 5.08 | 6.7 score on a scale STANDARD_DEVIATION 4.83 | 6.7 score on a scale STANDARD_DEVIATION 4.92 |
| Age, Categorical <=18 years | 49 Participants | 54 Participants | 103 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.1 years STANDARD_DEVIATION 3.02 | 10.8 years STANDARD_DEVIATION 3.01 | 10.9 years STANDARD_DEVIATION 3 |
| Clinical Global Impression - Severity (CGI-S) | 4.76 score on a scale STANDARD_DEVIATION 0.63 | 4.82 score on a scale STANDARD_DEVIATION 0.684 | 4.79 score on a scale STANDARD_DEVIATION 0.656 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Multiple | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 42 Participants | 74 Participants |
| Sex: Female, Male Female | 13 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 36 Participants | 47 Participants | 83 Participants |
| Vineland Adaptive Behavior Scales Social and Communication Composite Score | 66.6 score on a scale STANDARD_DEVIATION 19.61 | 67.7 score on a scale STANDARD_DEVIATION 15.18 | 67.2 score on a scale STANDARD_DEVIATION 17.41 |
| WASI-II Intelligent Quotient Score | 99.42 score on a scale STANDARD_DEVIATION 18.03 | 100.89 score on a scale STANDARD_DEVIATION 17.16 | 100.19 score on a scale STANDARD_DEVIATION 17.49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 54 |
| other Total, other adverse events | 14 / 49 | 20 / 54 |
| serious Total, serious adverse events | 2 / 49 | 1 / 54 |
Outcome results
Primary
Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores
The caregiver-assessed ABC was designed to assess the presence and severity of various problem behaviors commonly observed in individuals diagnosed with intellectual and developmental disability. The checklist contains 5 subscales: Irritability (15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). The total score of all items for each subscale range from 0-45 (irritability), 0-48 (social withdrawal and hyperactivity/noncompliance), 0-21 (stereotypic behavior), and 0-12 (inappropriate speech) where higher scores indicate worse clinical outcome. The change from baseline to Week 4, Week 8, and Week 12 is reported with lower scores indicating better clinical outcome.
Time frame: Baseline up to Week 12
Population: Aberrant behavior checklist subscale total scores were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Social Withdrawal, Week 8 | -3.81 score on a scale | Standard Deviation 6.76 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Stereotypic Behavior, Week 12 | -1.88 score on a scale | Standard Deviation 3.63 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Irritability, Week 8 | -6.67 score on a scale | Standard Deviation 8.63 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Hyperactivity/Noncompliance, Week 4 | -5.73 score on a scale | Standard Deviation 8.08 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Social Withdrawal, Week 12 | -3.74 score on a scale | Standard Deviation 6.21 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Hyperactivity/Noncompliance, Week 8 | -6.39 score on a scale | Standard Deviation 9.15 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Social Withdrawal, Week 4 | -2.53 score on a scale | Standard Deviation 5.61 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Hyperactivity/Noncompliance, Week 12 | -6.74 score on a scale | Standard Deviation 10.62 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Stereotypic Behavior, Week 4 | -2.10 score on a scale | Standard Deviation 4.24 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Inappropriate Speech, Week 4 | -2.13 score on a scale | Standard Deviation 2.88 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Irritability, Week 12 | -6.97 score on a scale | Standard Deviation 9.68 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Inappropriate Speech, Week 8 | -1.58 score on a scale | Standard Deviation 2.74 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Stereotypic Behavior, Week 8 | -1.92 score on a scale | Standard Deviation 3.99 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Inappropriate Speech, Week 12 | -1.94 score on a scale | Standard Deviation 2.93 |
| GWP42003-P | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Irritability, Week 4 | -6.35 score on a scale | Standard Deviation 7.98 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Inappropriate Speech, Week 12 | -1.51 score on a scale | Standard Deviation 2.97 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Irritability, Week 4 | -5.41 score on a scale | Standard Deviation 7.16 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Irritability, Week 8 | -8.05 score on a scale | Standard Deviation 9.12 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Irritability, Week 12 | -8.57 score on a scale | Standard Deviation 10.1 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Social Withdrawal, Week 4 | -2.92 score on a scale | Standard Deviation 5.24 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Social Withdrawal, Week 8 | -4.74 score on a scale | Standard Deviation 6.25 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Social Withdrawal, Week 12 | -4.51 score on a scale | Standard Deviation 5.95 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Stereotypic Behavior, Week 4 | -1.39 score on a scale | Standard Deviation 3.24 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Stereotypic Behavior, Week 8 | -1.98 score on a scale | Standard Deviation 4.05 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Stereotypic Behavior, Week 12 | -2.31 score on a scale | Standard Deviation 4.03 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Hyperactivity/Noncompliance, Week 4 | -4.55 score on a scale | Standard Deviation 8.15 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Hyperactivity/Noncompliance, Week 8 | -7.42 score on a scale | Standard Deviation 9.06 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Hyperactivity/Noncompliance, Week 12 | -8.77 score on a scale | Standard Deviation 9.94 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Inappropriate Speech, Week 4 | -0.88 score on a scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | ABC-Inappropriate Speech, Week 8 | -1.44 score on a scale | Standard Deviation 2.73 |
Comparison: Irritability (Week 12)p-value: =0.08595% CI: [-0.48, 7.21]Mixed models for repeated measures
Comparison: Social Withdrawal Week 12)p-value: =0.310795% CI: [-1.08, 3.36]Mixed models for repeated measures
Comparison: Stereotypic Behavior (Week 12)p-value: =0.951395% CI: [-1.34, 1.42]Mixed models for repeated measures
Comparison: Hyperactivity/Noncompliance (Week 12)p-value: =0.30595% CI: [-1.86, 5.88]Mixed models repeated measures
Comparison: Inappropriate Speech (Week 12)p-value: =0.475495% CI: [-1.4, 0.66]Mixed models repeated measures
Primary
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's experience with patients who have the same diagnosis. The clinician is asked: Considering your total clinical experience with this particular population, how ill is the patient at this time? This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Higher scores indicate worse outcome. The change from baseline in CGI-S scores is reported and lower mean scores indicate better outcome.
Time frame: Baseline up to Week 12
Population: CGI-S was assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 4 | -0.33 score on a scale | Standard Deviation 0.61 |
| GWP42003-P | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 8 | -0.50 score on a scale | Standard Deviation 0.68 |
| GWP42003-P | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 12 | -0.55 score on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 4 | -0.31 score on a scale | Standard Deviation 0.69 |
| Placebo | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 8 | -0.48 score on a scale | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 12 | -0.63 score on a scale | Standard Deviation 1.1 |
Comparison: Week 12p-value: =0.6108Cochran-Mantel-Haenszel
Primary
Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores
The VABS-3 scales assess what a person does, rather than what he or she can do. The Vineland-3 assesses adaptive behavior in 3 domains: Communication, Daily Living Skills, and Socialization. Each domain is comprised of 3 subdomains: receptive expression and written (communication); personal, domestic and community (daily living skills); Interpersonal relationships, play and leisure and copying skills (socialization). The adaptive behavior composite score is calculated as arithmetic mean of all 3 domain scores. The total score range is 20 to 140, where low scores indicate low (worst) clinical outcome and high scores indicate high (best) clinical outcome. The change from baseline in VABS-3 is being reported with positive values indicating a positive improvement in adaptive behavior.
Time frame: Baseline up to Week 12
Population: Vineland Adaptive Behavior Scales-3 (VABS-3) scores were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Week 4 | 2.97 score on a scale | Standard Deviation 6.7 |
| GWP42003-P | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Week 8 | 3.69 score on a scale | Standard Deviation 10.82 |
| GWP42003-P | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Week 12 | 4.85 score on a scale | Standard Deviation 8.83 |
| Placebo | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Week 4 | 0.99 score on a scale | Standard Deviation 9.29 |
| Placebo | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Week 8 | 3.54 score on a scale | Standard Deviation 8.83 |
| Placebo | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Week 12 | 5.55 score on a scale | Standard Deviation 10.42 |
Comparison: Week 12p-value: =0.850695% CI: [-4.26, 5.15]Mixed models for repeated measures
Primary
Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category
The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The clinician is asked: Compared to the patient's condition at admission to the project, how much has the patient changed? This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Higher scores indicate worse clinical outcome. The number of patients in each CGI-I category is reported.
Time frame: Day 85
Population: Patients per CGI-I category were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | No change | 9 Participants |
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Very much improved | 0 Participants |
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Much improved | 12 Participants |
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Minimally worse | 0 Participants |
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Much worse | 0 Participants |
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Very much worse | 0 Participants |
| GWP42003-P | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Minimally improved | 13 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Very much worse | 0 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Minimally improved | 14 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Much improved | 11 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | No change | 11 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Much worse | 1 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Very much improved | 1 Participants |
| Placebo | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Minimally worse | 0 Participants |
Comparison: Responders with 'Very Much Improved' or 'Much Improved' response at week 12p-value: =0.708795% CI: [0.43, 3.51]Regression, Logistic
Secondary
Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels
Time frame: Week 9 (end of taper/withdrawal)
Population: Erythrocyte mean corpuscular hemoglobin levels were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P | Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels | 0.13 pg/cell | Standard Deviation 0.67 |
| Placebo | Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels | -0.03 pg/cell | Standard Deviation 0.72 |
Secondary
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels
Time frame: Week 9 (end of taper/withdrawal)
Population: Erythrocyte mean corpuscular volume levels were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P | Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels | 0.52 fL | Standard Deviation 2.32 |
| Placebo | Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels | 0.03 fL | Standard Deviation 2.39 |
Secondary
Mean Change From Baseline in Hematology Clinical Laboratory Levels
Time frame: Baseline up to Week 9 (end of taper/withdrawal)
Population: Hematology clinical laboratory levels were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Lymphocytes | 0.04 10^9 cells/L | Standard Deviation 0.7 |
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Neutrophils | 0.04 10^9 cells/L | Standard Deviation 1.8 |
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Eosinophils | -0.09 10^9 cells/L | Standard Deviation 0.311 |
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Platelets | -9.43 10^9 cells/L | Standard Deviation 34.5 |
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Monocytes | -0.01 10^9 cells/L | Standard Deviation 0.15 |
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Leukocytes | -0.02 10^9 cells/L | Standard Deviation 1.87 |
| GWP42003-P | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Basophils | -0.01 10^9 cells/L | Standard Deviation 0.03 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Leukocytes | -0.23 10^9 cells/L | Standard Deviation 1.79 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Basophils | 0 10^9 cells/L | Standard Deviation 0.03 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Eosinophils | 0 10^9 cells/L | Standard Deviation 0.4 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Lymphocytes | -0.20 10^9 cells/L | Standard Deviation 0.68 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Monocytes | -0.01 10^9 cells/L | Standard Deviation 0.19 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Neutrophils | -0.01 10^9 cells/L | Standard Deviation 1.26 |
| Placebo | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Platelets | 8.43 10^9 cells/L | Standard Deviation 52.13 |
Secondary
Mean Change From Baseline in Hemoglobin Levels
Time frame: Week 9 (end of taper/withdrawal)
Population: Hemoglobin levels were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GWP42003-P | Mean Change From Baseline in Hemoglobin Levels | -0.06 g/dL | Standard Deviation 0.55 |
| Placebo | Mean Change From Baseline in Hemoglobin Levels | 0.08 g/dL | Standard Deviation 0.65 |
Secondary
Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels
Time frame: Baseline up to Week 9 (end of taper/withdrawal)
Population: Hematology clinical laboratory levels were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Basophils/Leukocytes | -0.07 percentage change from baseline | Standard Deviation 0.45 |
| GWP42003-P | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Eosinophils/Leukocytes | -1.33 percentage change from baseline | Standard Deviation 5.37 |
| GWP42003-P | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Hematocrit | -0.02 percentage change from baseline | Standard Deviation 2.19 |
| GWP42003-P | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Lymphocytes/Leukocytes | 1.05 percentage change from baseline | Standard Deviation 11.25 |
| GWP42003-P | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Monocytes/Leukocytes | -0.16 percentage change from baseline | Standard Deviation 2.04 |
| GWP42003-P | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Neutrophils/Leukocytes | 0.49 percentage change from baseline | Standard Deviation 12.29 |
| Placebo | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Monocytes/Leukocytes | 0.05 percentage change from baseline | Standard Deviation 1.86 |
| Placebo | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Basophils/Leukocytes | -0.03 percentage change from baseline | Standard Deviation 0.42 |
| Placebo | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Lymphocytes/Leukocytes | -2.32 percentage change from baseline | Standard Deviation 8.26 |
| Placebo | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Eosinophils/Leukocytes | 0.22 percentage change from baseline | Standard Deviation 4.88 |
| Placebo | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Neutrophils/Leukocytes | 2.08 percentage change from baseline | Standard Deviation 8.89 |
| Placebo | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Week 9: Hematocrit | 0.43 percentage change from baseline | Standard Deviation 2.3 |
Secondary
Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS rating scale results since last visit is reported. The presence/absence of any suicidal ideation or behavior is scored based on yes/no responses. The overall number of participants reporting suicidal ideation or behavior is being reported.
Time frame: Baseline up to Day 92
Population: Suicidal ideation or behavior was assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 4 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Wish to be dead | 3 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Non-specific active suicidal thoughts | 2 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Active suicidal ideation, no intent to act | 1 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Active suicidal ideation, some intent to act | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Active suicidal ideation, specific plan/intent | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 3 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Actual attempt | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Interrupted attempt | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Aborted attempt | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Preparatory acts or behavior | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior item | 0 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent | 3 Participants |
| GWP42003-P | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed suicide | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Preparatory acts or behavior | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 3 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Actual attempt | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Wish to be dead | 3 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior without suicidal intent | 5 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Non-specific active suicidal thoughts | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Interrupted attempt | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Active suicidal ideation, no intent to act | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior item | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Active suicidal ideation, some intent to act | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Aborted attempt | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Active suicidal ideation, specific plan/intent | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed suicide | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 6 Participants |
Secondary
Number of Participants Reporting Treatment-emergent Adverse Events
A TEAE is one that started, or worsened in severity or seriousness, following the first dose of IMP. AEs were coded according to the Medical Dictionary for Regulatory Activities v24.0 dictionary.
Time frame: Baseline up to Week 12
Population: Adverse events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | Non-TEAE | 25 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE leading to study intervention withdrawal | 2 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | Serious TEAE | 2 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | Treatment-related TEAE leading to drug withdrawal | 1 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | Treatment-related TEAE | 6 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE leading to withdrawal | 2 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | Serious Treatment-related TEAE | 0 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE leading to death | 0 Participants |
| GWP42003-P | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE | 27 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE leading to death | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE | 24 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | Non-TEAE | 32 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | Treatment-related TEAE | 10 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | Serious TEAE | 1 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | Serious Treatment-related TEAE | 0 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE leading to study intervention withdrawal | 1 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | Treatment-related TEAE leading to drug withdrawal | 1 Participants |
| Placebo | Number of Participants Reporting Treatment-emergent Adverse Events | TEAE leading to withdrawal | 2 Participants |
Secondary
Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings
Time frame: Baseline up to Day 85 post-baseline
Population: Clinically significant 12-lead electrocardiogram were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | QTcB >450 msec | 7 Participants |
| GWP42003-P | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | QTcB >480 msec | 2 Participants |
| GWP42003-P | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | QTcB >500 msec | 1 Participants |
| Placebo | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | QTcB >450 msec | 4 Participants |
| Placebo | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | QTcB >480 msec | 0 Participants |
| Placebo | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | QTcB >500 msec | 0 Participants |
Secondary
Number of Patients With Clinically Significant Physical Examination Procedure Findings
Number of patients with abnormal physical exam findings are reported.
Time frame: Baseline up to Day 85 post-baseline
Population: Abnormal physical exam findings were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Chest/lungs | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | HEENT | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Endocrine system | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Lymphatic | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Cardiovascular | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Musculoskeletal/Extremities | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Gastrointestinal | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Neurological | 2 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Dermatological | 3 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Other | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | General appearance | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Genitourinary/Reproductive | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Abdomen | 2 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Genitourinary/Reproductive | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Abdomen | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Cardiovascular | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Chest/lungs | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Dermatological | 3 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Endocrine system | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Gastrointestinal | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | General appearance | 2 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | HEENT | 1 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Lymphatic | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Musculoskeletal/Extremities | 1 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Neurological | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Other | 0 Participants |
Secondary
Number of Patients With Clinically Significant Vital Sign Values
Time frame: Post-baseline up to 12 weeks
Population: Vital signs were assessed in participants with available data in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Increase in weight from baseline >7% | 7 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Decrease in weight from baseline >7% | 2 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Body temperature <36 degrees Celsius | 4 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Body temperature >38 degrees Celsius | 1 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Pulse rate <60 beats/min | 1 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Pulse rate >100 beats/min | 7 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Respiratory rate <12 breaths/min | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Respiratory rate >20 breaths/min | 13 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Systolic blood pressure <90 mmhg | 5 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Systolic blood pressure >160 mmhg | 0 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Diastolic blood pressure <50 mmhg | 3 Participants |
| GWP42003-P | Number of Patients With Clinically Significant Vital Sign Values | Diastolic blood pressure >120 mmhg | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Diastolic blood pressure <50 mmhg | 2 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Increase in weight from baseline >7% | 13 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Respiratory rate <12 breaths/min | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Decrease in weight from baseline >7% | 2 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Systolic blood pressure >160 mmhg | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Body temperature <36 degrees Celsius | 6 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Respiratory rate >20 breaths/min | 17 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Body temperature >38 degrees Celsius | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Diastolic blood pressure >120 mmhg | 0 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Pulse rate <60 beats/min | 3 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Systolic blood pressure <90 mmhg | 3 Participants |
| Placebo | Number of Patients With Clinically Significant Vital Sign Values | Pulse rate >100 beats/min | 4 Participants |