Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002819-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GWP42003-P 10 mg/kg/day | Experimental | Participants will be stratified based on their age (6 to 11 years old, 12 to 17 years old), use of antipsychotics (on versus off), and region (North America versus Rest of the World) and will be randomized to receive 5 milligrams per kilogram per day (mg/kg/day) GWP42003-P for 1 week and then 10 mg/kg/day GWP42003-P for 11 weeks. |
|
| Placebo | Placebo Comparator | Participants will be stratified based on their age (6 to 11 years old, 12 to 17 years old), use of antipsychotics (on versus off), and region (North America versus Rest of the World) and will be randomized to receive matching placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWP42003-P | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 12 |
| 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. | Baseline up to Week 12 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 12 |
| Mean Change From Baseline in Hematology Clinical Laboratory Levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research and Resource Center (SARRRC) | Phoenix | Arizona | 85006 | United States | ||
| UCSD School of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2020 | Dec 16, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | 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) |
|
| Day 85 |
| 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. | Baseline up to Week 12 |
| 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) |
| 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 Patients With Clinically Significant Physical Examination Procedure Findings | Number of patients with abnormal physical exam findings are reported. | Baseline up to Day 85 post-baseline |
| 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) | 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. | Baseline up to Day 92 |
| La Jolla |
| California |
| 92093 |
| United States |
| UCLA Neuropsychiatric Institute | Los Angeles | California | 90024 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| APG Research, LLC | Orlando | Florida | 32803 | United States |
| University of Louisville | Louisville | Kentucky | 40292 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Massachusetts General Hospital (Lurie Center for Autism) | Lexington | Massachusetts | 02421 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Seattle Children's Research Institute | Seattle | Washington | 98105 | United States |
| Monash Medical Centre | Clayton | 03168 | Australia |
| Queensland Children's Hospital | South Brisbane | 4101 | Australia |
| The Kids Clinic | Ajax | Ontario | L1Z0M1 | Canada |
| Center for Pediatric Excellence | Ottawa | Ontario | K2G1W2 | Canada |
| Klinik fur Psychiatrie, Psychotherapie und Psychosomatik im Kindes und Jugendalter | Freiburg im Breisgau | 79104 | Germany |
| Zentralinstitut fuer Seelische Gesundheit | Mannheim | 68159 | Germany |
| Instituto Global de Atencion Integral del Neurodesarrollo (IGAIN) | Barcelona | 08007 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 08208 | Spain |
| University of Glasgow Institute of Health and Wellbeing | Glasgow | G128QQ | United Kingdom |
| Institute of Psychiatry, King's College London | London | United Kingdom |
Patients who were randomized to placebo for 12 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Demographic and baseline characteristics were assessed in the Safety Analysis Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo | Patients who were randomized to placebo for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| WASI-II Intelligent Quotient Score | The WASI-II raw score is converted into T-scores and then summed to derive the composite score, which ranges from 70 (worst outcome) to 160 (best outcome). Composite score performance categories are: Profoundly high=150-160, Superior= 130-160, Very high=120-129, Bright normal=110-119, Average=90-109, Low average=80-89, and Borderline=70-79. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Aberrant Behavior Checklist Irritability | On the Aberrant Behavior Checklist (ABC), the irritability score is based on a 15-item subscale where each item is rated on a 4-point scale, ranging from 0 (not a problem) to 3 (severe problem). The total score ranges from 0 to 45, with higher scores indicating worst clinical outcome and lower scores indicating better clinical outcome. | Aberrant Behavior Checklist Irritability was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Aberrant Behavior Checklist Social Withdrawal | On the Aberrant Behavior Checklist (ABC), the social withdrawal score is based on a 16-item subscale where each item is rated on a 4-point scale, ranging from 0 (not a problem) to 3 (severe problem). The total score ranges from 0 to 48, with higher scores indicating worst clinical outcome and lower scores indicating better clinical outcome. | Aberrant Behavior Checklist Social Withdrawal was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Aberrant Behavior Checklist Stereotypic Behavior | On the Aberrant Behavior Checklist (ABC), the stereotypic behavior score is based on a 7-item subscale where each item is rated on a 4-point scale, ranging from 0 (not a problem) to 3 (severe problem). The total score ranges from 0 to 21, with higher scores indicating worst clinical outcome and lower scores indicating better clinical outcome. | Aberrant Behavior Checklist Stereotypic Behavior was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Aberrant Behavior Checklist Hyperactivity/Noncompliance | On the Aberrant Behavior Checklist (ABC), the hyperactivity/noncompliance score is based on a 16-item subscale where each item is rated on a 4-point scale, ranging from 0 (not a problem) to 3 (severe problem). The total score ranges from 0 to 48, with higher scores indicating worst clinical outcome and lower scores indicating better clinical outcome. | Aberrant Behavior Checklist Hyperactivity/Noncompliance was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Aberrant Behavior Checklist Inappropriate Speech | On the Aberrant Behavior Checklist (ABC), the inappropriate speech score is based on a 4-item subscale where each item is rated on a 4-point scale, ranging from 0 (not a problem) to 3 (severe problem). The total score ranges from 0 to 12, with higher scores indicating worst clinical outcome and lower scores indicating better clinical outcome. | Aberrant Behavior Checklist Inappropriate Speech was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Vineland Adaptive Behavior Scales Social and Communication Composite Score | The Vineland Social and Communication Composite Score ranges from 20 (worst clinical outcome) to 160 (best clinical outcome). Scores from 115 to 160 is above average, 86 to 114 average, 71 to 85 below average, and below 70 low. | Vineland Adaptive Behavior Scales Social and Communication Composite Score was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Clinical Global Impression - Severity (CGI-S) | 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. | Clinical Global Impression - Severity (CGI-S) was assessed in participants with available data in the Full Analysis Set. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Aberrant behavior checklist subscale total scores were assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Vineland Adaptive Behavior Scales-3 (VABS-3) scores were assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients per CGI-I category were assessed in participants with available data in the Full Analysis Set. | Posted | Count of Participants | Participants | Day 85 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | CGI-S was assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Adverse events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Hematology clinical laboratory levels were assessed in participants with available data in the Safety Analysis Set. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline up to Week 9 (end of taper/withdrawal) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Hematology clinical laboratory levels were assessed in participants with available data in the Safety Analysis Set. | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline up to Week 9 (end of taper/withdrawal) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Hemoglobin Levels | Hemoglobin levels were assessed in participants with available data in the Safety Analysis Set. | Posted | Mean | Standard Deviation | g/dL | Week 9 (end of taper/withdrawal) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels | Erythrocyte mean corpuscular hemoglobin levels were assessed in participants with available data in the Safety Analysis Set. | Posted | Mean | Standard Deviation | pg/cell | Week 9 (end of taper/withdrawal) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels | Erythrocyte mean corpuscular volume levels were assessed in participants with available data in the Safety Analysis Set. | Posted | Mean | Standard Deviation | fL | Week 9 (end of taper/withdrawal) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinically Significant Vital Sign Values | Vital signs were assessed in participants with available data in the Safety Analysis Set. | Posted | Count of Participants | Participants | Post-baseline up to 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Number of patients with abnormal physical exam findings are reported. | Abnormal physical exam findings were assessed in participants with available data in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to Day 85 post-baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | Clinically significant 12-lead electrocardiogram were assessed in participants with available data in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to Day 85 post-baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Suicidal ideation or behavior was assessed in participants with available data in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to Day 92 |
|
|
Adverse event data were collected from baseline up to 14 days after last dose, up to approximately 12 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 49 | 2 | 49 | 14 | 49 |
| EG001 | Placebo | Patients who were randomized to placebo for 12 weeks. | 0 | 54 | 1 | 54 | 20 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRAv24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRAv24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRAv24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRAv24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRAv24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRAv24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRAv24.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRAv24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRAv24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRAv24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Jazz Pharmaceuticals | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2023 | Dec 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
| Asian |
|
|
| Black or African American |
|
|
| White |
|
|
| Multiple |
|
|
| Unknown |
|
|
| Not Reported |
|
|
| Other |
|
|
|
|
|
|
|
|
|
|
| ABC-Irritability, Week 8 |
|
|
| ABC-Irritability, Week 12 |
|
|
| ABC-Social Withdrawal, Week 4 |
|
|
| ABC-Social Withdrawal, Week 8 |
|
|
| ABC-Social Withdrawal, Week 12 |
|
|
| ABC-Stereotypic Behavior, Week 4 |
|
|
| ABC-Stereotypic Behavior, Week 8 |
|
|
| ABC-Stereotypic Behavior, Week 12 |
|
|
| ABC-Hyperactivity/Noncompliance, Week 4 |
|
|
| ABC-Hyperactivity/Noncompliance, Week 8 |
|
|
| ABC-Hyperactivity/Noncompliance, Week 12 |
|
|
| ABC-Inappropriate Speech, Week 4 |
|
|
| ABC-Inappropriate Speech, Week 8 |
|
|
| ABC-Inappropriate Speech, Week 12 |
|
|
Social Withdrawal Week 12) |
| Mixed models for repeated measures |
Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated). |
| =0.3107 |
| Least square mean difference |
| 1.14 |
| Standard Error of the Mean |
| 1.16 |
| 2-Sided |
| 95 |
| -1.08 |
| 3.36 |
| Superiority |
| Stereotypic Behavior (Week 12) | Mixed models for repeated measures | Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated). | =0.9513 | Least square mean difference | 0.04 | Standard Error of the Mean | 0.695 | 2-Sided | 95 | -1.34 | 1.42 | Superiority |
| Hyperactivity/Noncompliance (Week 12) | Mixed models repeated measures | Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated). | =0.305 | Least square mean difference | 2.01 | Standard Error of the Mean | 1.943 | 2-Sided | 95 | -1.86 | 5.88 | Superiority |
| Inappropriate Speech (Week 12) | Mixed models repeated measures | Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated). | =0.4754 | Least square mean difference | -0.37 | Standard Error of the Mean | 0.517 | 2-Sided | 95 | -1.4 | 0.66 | Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|