CBDV Compound
CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC).
Loading study record…
Loading study record…
This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-05-07
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
This clinical research trial aims to study the feasibility and safety of cannabidivarin (CBDV), in children and young adults with Prader-Willi Syndrome (PWS). CBDV has effects independent of Cannabinoid Receptor Type 1 (CB1) and Cannabinoid Receptor Type 2 (CB2) receptor activation and a good safety profile. This proposal addresses the Foundation for Prader Willi Research's PWS Research Plan: Program 1, Clinical Care Research: seeks to evaluate treatments that aim to reduce behavioral symptoms, such as irritability, in order to improve the quality of life of both the individual with PWS and their families. GW Pharmaceuticals (since acquired by Jazz Pharmaceuticals) will provide the CBDV drug and matching placebo.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC).
Placebo oral solution contains matching excipients.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Irritability will be assessed using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I). The ABC-I is a well-characterized outcome that is accepted by the FDA for the purpose of labeling and is one of the best and most validated outcome measures in the developmental disabilities. The ABC-Irritability subscale consists of 15 questions that address the presence of irritability, aggression, tantrums and/or self-injury. Each item is rated on a scale ranging from 0 ("Not at all a problem") to 3 ("Severe problem"), resulting in a total score range of 0-45, such that higher ABC-I scores are indicative of more severe behavioral problems. Subjects must score an 18 or higher at screening to be included in the study. ABC-I scores for Week 4, Week 8, and Week 12 are summarized in the table by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 2 | 16.5 | 2.12 |
| Matched Placebo | 3 | 16.7 | 9.61 |
| Cannabidivarin (CBDV) | 2 | 11.0 | 5.66 |
| Matched Placebo | 3 | 12.3 | 5.51 |
| Cannabidivarin (CBDV) | 2 | 10.0 | 5.66 |
| Matched Placebo | 3 | 10.3 | 4.16 |
Eligibility
primary outcomes
Time frame: Baseline, Week 4, Week 8, Week 12
Irritability will be assessed using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I). The ABC-I is a well-characterized outcome that is accepted by the FDA for the purpose of labeling and is one of the best and most validated outcome measures in the developmental disabilities. The ABC-Irritability subscale consists of 15 questions that address the presence of irritability, aggression, tantrums and/or self-injury. Each item is rated on a scale ranging from 0 ("Not at all a problem") to 3 ("Severe problem"), resulting in a total score range of 0-45, such that higher ABC-I scores are indicative of more severe behavioral problems. Subjects must score an 18 or higher at screening to be included in the study. ABC-I scores for Week 4, Week 8, and Week 12 are summarized in the table by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
secondary outcomes
Time frame: Baseline, Week 4, Week 8, Week 12
Repetitive behavior will be evaluated using the RBS-R. RBS-R is a 43-item self-report questionnaire used to measure the breadth or repetitive behaviors in children, adolescents, and adults with ASD. The RBS-R consists of 6 subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Behavior that have no overlap of item content. Each of the 43 items are rated on a 4-point Likert scale ranging from 0 ("Behavior does not occur") to 3 ("Behavior occurs and is a severe problem"), yielding an overall scoring range of 0-129, such that higher scores are associated with increased severity of the problem behavior. RBS-R scores for Week 4, Week 8, and Week 12 are summarized in the table by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
Time frame: Baseline, Week 4, Week 8, Week 12
Obsessive-compulsive symptoms will be assessed using the CY-BOCS. The CY-BOCS is 10-item clinician-rated measure designed to assess the severity of obsessive-compulsive symptoms in children/adolescents over the prior week. It consists of 5 primary sections: Time, Distress, Interference, Resistance, and Control of Symptoms. The 10 items are rated on a scale from 0 ("No symptoms") to 4 ("Extreme symptoms"), for an overall possible range of 0-40, with higher scores indicative of greater severity of symptoms. CY-BOCS scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
Time frame: Baseline, Week 4, Week 8, Week 12
Hyperphagia will be assessed using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). The HQ-CT is a 9-item caregiver-reported measure of the frequency and intensity of food-seeking behaviors in participants with Prader-Willi Syndrome (PWS) over the prior two-week period. The 9 items are graded on a Likert scale ranging from 0 ("No Hyperphagia") to 4 ("Most severe hyperphagia"), yielding an overall possible scoring range of 0-36, with higher scores indicating greater, more severe hyperphagia. HQ-CT scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
Publications
Repetitive behavior will be evaluated using the RBS-R. RBS-R is a 43-item self-report questionnaire used to measure the breadth or repetitive behaviors in children, adolescents, and adults with ASD. The RBS-R consists of 6 subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Behavior that have no overlap of item content. Each of the 43 items are rated on a 4-point Likert scale ranging from 0 ("Behavior does not occur") to 3 ("Behavior occurs and is a severe problem"), yielding an overall scoring range of 0-129, such that higher scores are associated with increased severity of the problem behavior. RBS-R scores for Week 4, Week 8, and Week 12 are summarized in the table by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 2 | 21.0 | 9.90 |
| Matched Placebo | 3 | 27.0 | 14.2 |
| Cannabidivarin (CBDV) | 2 | 16.0 | 12.7 |
| Matched Placebo | 3 | 22.7 | 7.51 |
| Cannabidivarin (CBDV) | 2 | 15.5 | 10.6 |
| Matched Placebo | 3 | 17.7 | 8.39 |
Obsessive-compulsive symptoms will be assessed using the CY-BOCS. The CY-BOCS is 10-item clinician-rated measure designed to assess the severity of obsessive-compulsive symptoms in children/adolescents over the prior week. It consists of 5 primary sections: Time, Distress, Interference, Resistance, and Control of Symptoms. The 10 items are rated on a scale from 0 ("No symptoms") to 4 ("Extreme symptoms"), for an overall possible range of 0-40, with higher scores indicative of greater severity of symptoms. CY-BOCS scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
Population: Data was missing from one of the participants in the CBDV arm/group.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 2 | 13.0 | 4.24 |
| Matched Placebo | 3 | 15.3 | 3.51 |
| Cannabidivarin (CBDV) | 2 | 9.50 | 0.71 |
| Matched Placebo | 3 | 15.7 | 3.06 |
| Cannabidivarin (CBDV) | 2 | 7.00 | - |
| Matched Placebo | 3 | 13.5 | 3.54 |
Hyperphagia will be assessed using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). The HQ-CT is a 9-item caregiver-reported measure of the frequency and intensity of food-seeking behaviors in participants with Prader-Willi Syndrome (PWS) over the prior two-week period. The 9 items are graded on a Likert scale ranging from 0 ("No Hyperphagia") to 4 ("Most severe hyperphagia"), yielding an overall possible scoring range of 0-36, with higher scores indicating greater, more severe hyperphagia. HQ-CT scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
Population: Hyperphagia data was available for all Week 4 participants.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 3 | 12.7 | 6.35 |
| Matched Placebo | 3 | 15.3 | 4.51 |
| Cannabidivarin (CBDV) | 3 | 9.00 | 2.83 |
| Matched Placebo | 3 | 15.0 | 2.65 |
| Cannabidivarin (CBDV) | 3 | 11.0 | 1.41 |
| Matched Placebo | 3 | 14.3 | 7.57 |
Global Functioning will be assessed using the Clinical Global Impression Scale - Improvement (CGI-I). The CGI-I is a global assessment which measures the change in a participant's illness severity, relative to a baseline, considering all symptoms, behaviors, and functional impairment. It consists of a 7-point clinician-rated scale as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. such that higher scores are indicative of worsening global function. CGI-I scores for Week 4, Week 8, and Week 12 are summarized by study arm using basic descriptive statistics.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 2 | 3.00 | 1.41 |
| Matched Placebo | 3 | 3.67 | 0.58 |
| Cannabidivarin (CBDV) | 2 | 2.50 | 0.71 |
| Matched Placebo | 3 | 3.33 | 0.58 |
| Cannabidivarin (CBDV) | 2 | 3.50 | 0.71 |
| Matched Placebo | 3 | 2.67 | 0.58 |
Caregiver Strain will be evaluated using the Caregiver Strain Questionnaire (CSQ). The CSQ is a 21-item self-report questionnaire, consisting of 3 subscales, developed to assess caregiver strain/stress for families with a child living with an emotional or behavioral disorder. Items 1-11 assess Objective Strain. Items 12, 16-18, and 20-21 assess Subjective Internalized Strain. Items 13-15, and 19 assess Subjective Externalize Strain. All CSQ items are rated from 1 ("Not at all a problem") to 5 ("Very much a problem"). Scores are calculated by averaging items within each subscale to handle missing data and calculating a Global Score by summing the 3 subscale means for a total possible scale range of 3-15. Higher Global Scores are associated with increased Caregiver Strain. Global results scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 2 | 9.38 | 3.05 |
| Matched Placebo | 3 | 7.36 | 3.79 |
| Cannabidivarin (CBDV) | 2 | 9.09 | 1.32 |
| Matched Placebo | 3 | 7.95 | 3.10 |
| Cannabidivarin (CBDV) | 2 | 8.73 | 2.87 |
| Matched Placebo | 3 | 7.62 | 2.86 |
Rigid behavior will be assessed based using the MERS-R-PWS. The MERS-R-PWS is a clinician-rated scale designed to assess 3 domains of rigid behavior in individuals with PWS: Behavioral Rigidity (e.g., Insistence on sameness, things must be done in his/her way, etc.) Cognitive Rigidity (e.g., Special interests, inflexible adherence to rules, etc.) Protest (in response to deviation from rigidity; e.g., tantrum, irritability, arguing) Each domain consists of 4 items rated on a 5-point scale ranging from 0 ("No/None/Not difficult") to 4 ("Extreme/Extremely Difficult"), yielding a range of 0-16. Scores at Week 12 will only be completed for subjects who display rigid behaviors at baseline, week 4, week 8 and week 12. A total MERS-R-PWS score (0-48) is obtained by summing subscale score. Individual subscale scores (0-16) are also summarized. Higher MERS-R-PWS scores are indicative of greater rigidity within each domain and overall rigidity.
Population: Full week 12 scores were available for the CBDV arm for this outcome measure as data was imputed.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 3 | 13.7 | 2.65 |
| Matched Placebo | 3 | 28.3 | 3.06 |
| Cannabidivarin (CBDV) | 3 | 1.33 | 2.31 |
| Matched Placebo | 3 | 8.67 | 3.79 |
| Cannabidivarin (CBDV) | 3 | 8.33 | 4.16 |
| Matched Placebo | 3 | 11.0 | 3.00 |
| Cannabidivarin (CBDV) | 3 | 4.00 | 2.65 |
| Matched Placebo | 3 | 8.67 | 3.06 |
Aberrant Behavior will be assessed using the Aberrant Behavior Checklist (ABC). The ABC is a 58-item informative rating instrument used to measure maladaptive behaviors in individuals with developmental disabilities and ASD which resolves into 5 subscales: Irritability (15 items); Lethargy/Social withdrawal (16 items); Stereotypic behavior (7 items); Hyperactivity/noncompliance (16 items); and Inappropriate speech (4 items). The ABC is completed by a parent/caregiver who knows the participant well. The ABC measures behavior on a 4-point Likert severity scale: (0 = "Not all a problem," 1 = "Slight problem," 2 = "Moderately serious problem," and 3 = "Severe problem"). Scores for 4 of the 5 subscales are reported below (ABC-I results reported as part of the primary outcome). Higher ABC subscale scores indicate greater behavioral severity/dysfunction of that subscale. Week 4, Week 8, and Week 12 scores are summarized by study arm. See Baseline Characteristics module for baseline data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidivarin (CBDV) | 2 | 12.5 | 9.19 |
| Matched Placebo | 3 | 3.33 | 3.51 |
| Cannabidivarin (CBDV) | 2 | 15.0 | 5.66 |
| Matched Placebo | 3 | 4.00 | 6.93 |
| Cannabidivarin (CBDV) | 2 | 12.5 | 7.78 |
| Matched Placebo | 3 | 3.67 | 4.73 |
| Cannabidivarin (CBDV) | 2 | 4.50 | 6.36 |
| Matched Placebo | 3 | 3.33 | 4.93 |
| Cannabidivarin (CBDV) | 2 | 3.00 | 4.24 |
| Matched Placebo | 3 | 2.33 | 3.22 |
| Cannabidivarin (CBDV) | 2 | 3.50 | 4.95 |
| Matched Placebo | 3 | 2.67 | 3.79 |
| Cannabidivarin (CBDV) | 2 | 11.0 | 14.1 |
| Matched Placebo | 3 | 19.3 | 2.31 |
| Cannabidivarin (CBDV) | 2 | 8.00 | 11.3 |
| Matched Placebo | 3 | 20.0 | 4.58 |
| Cannabidivarin (CBDV) | 2 | 9.00 | 12.7 |
| Matched Placebo | 3 | 15.0 | 5.00 |
| Cannabidivarin (CBDV) | 2 | 3.50 | 3.54 |
| Matched Placebo | 3 | 3.67 | 1.16 |
| Cannabidivarin (CBDV) | 2 | 3.00 | 4.24 |
| Matched Placebo | 3 | 1.33 | 0.58 |
| Cannabidivarin (CBDV) | 2 | 3.00 | 4.24 |
| Matched Placebo | 3 | 3.00 | 1.73 |
Sleep quality will be assessed using ActiGraph GT9X-BT® activity monitors. Successfully screened patients will receive the actigraphy device prior to the onsite baseline visit and will record a minimum of three days of baseline activity data prior to study initiation. The ActiGraph GT9X-BT activity monitors are a well validated activity and sleep monitoring device widely utilized in clinical trials and health research. For this study the ActiGraph monitors will measure: Sleep Latency (the time it takes to fall asleep), Total Sleep Time (the total amount of time spent asleep), and sleep efficiency (percentage of time in bed actually spent sleeping). Sleep data is captured automatically via cloud service. All parameters will be reported in hours/minutes and summarized by study arm.
Population: Sleep quality parameters from the ActiGraph device were not collected since the ActiGraphs were never purchased and administered. No data will ever exist for this Outcome Measure.
| Milestone | Cannabidivarin (CBDV) | Matched Placebo |
|---|---|---|
| STARTED | 3 | 3 |
| COMPLETED | 2 | 3 |
| NOT COMPLETED | 1 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dissociative Symptoms | General disorders | Cannabidivarin (CBDV): 1 / 3 · Matched Placebo: 0 / 3 |
Time frame: Week 4, Week 8, Week 12
Global Functioning will be assessed using the Clinical Global Impression Scale - Improvement (CGI-I). The CGI-I is a global assessment which measures the change in a participant's illness severity, relative to a baseline, considering all symptoms, behaviors, and functional impairment. It consists of a 7-point clinician-rated scale as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. such that higher scores are indicative of worsening global function. CGI-I scores for Week 4, Week 8, and Week 12 are summarized by study arm using basic descriptive statistics.
Time frame: Baseline, Week 4, Week 8, Week 12
Caregiver Strain will be evaluated using the Caregiver Strain Questionnaire (CSQ). The CSQ is a 21-item self-report questionnaire, consisting of 3 subscales, developed to assess caregiver strain/stress for families with a child living with an emotional or behavioral disorder. Items 1-11 assess Objective Strain. Items 12, 16-18, and 20-21 assess Subjective Internalized Strain. Items 13-15, and 19 assess Subjective Externalize Strain. All CSQ items are rated from 1 ("Not at all a problem") to 5 ("Very much a problem"). Scores are calculated by averaging items within each subscale to handle missing data and calculating a Global Score by summing the 3 subscale means for a total possible scale range of 3-15. Higher Global Scores are associated with increased Caregiver Strain. Global results scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics. Baseline results for this outcome can be found in the Baseline Characteristics module.
Time frame: Week 12
Rigid behavior will be assessed based using the MERS-R-PWS. The MERS-R-PWS is a clinician-rated scale designed to assess 3 domains of rigid behavior in individuals with PWS: Behavioral Rigidity (e.g., Insistence on sameness, things must be done in his/her way, etc.) Cognitive Rigidity (e.g., Special interests, inflexible adherence to rules, etc.) Protest (in response to deviation from rigidity; e.g., tantrum, irritability, arguing) Each domain consists of 4 items rated on a 5-point scale ranging from 0 ("No/None/Not difficult") to 4 ("Extreme/Extremely Difficult"), yielding a range of 0-16. Scores at Week 12 will only be completed for subjects who display rigid behaviors at baseline, week 4, week 8 and week 12. A total MERS-R-PWS score (0-48) is obtained by summing subscale score. Individual subscale scores (0-16) are also summarized. Higher MERS-R-PWS scores are indicative of greater rigidity within each domain and overall rigidity.
Time frame: Baseline, Week 4, Week 8, Week 12
Aberrant Behavior will be assessed using the Aberrant Behavior Checklist (ABC). The ABC is a 58-item informative rating instrument used to measure maladaptive behaviors in individuals with developmental disabilities and ASD which resolves into 5 subscales: Irritability (15 items); Lethargy/Social withdrawal (16 items); Stereotypic behavior (7 items); Hyperactivity/noncompliance (16 items); and Inappropriate speech (4 items). The ABC is completed by a parent/caregiver who knows the participant well. The ABC measures behavior on a 4-point Likert severity scale: (0 = "Not all a problem," 1 = "Slight problem," 2 = "Moderately serious problem," and 3 = "Severe problem"). Scores for 4 of the 5 subscales are reported below (ABC-I results reported as part of the primary outcome). Higher ABC subscale scores indicate greater behavioral severity/dysfunction of that subscale. Week 4, Week 8, and Week 12 scores are summarized by study arm. See Baseline Characteristics module for baseline data.
Time frame: Baseline through Week 12
Sleep quality will be assessed using ActiGraph GT9X-BT® activity monitors. Successfully screened patients will receive the actigraphy device prior to the onsite baseline visit and will record a minimum of three days of baseline activity data prior to study initiation. The ActiGraph GT9X-BT activity monitors are a well validated activity and sleep monitoring device widely utilized in clinical trials and health research. For this study the ActiGraph monitors will measure: Sleep Latency (the time it takes to fall asleep), Total Sleep Time (the total amount of time spent asleep), and sleep efficiency (percentage of time in bed actually spent sleeping). Sleep data is captured automatically via cloud service. All parameters will be reported in hours/minutes and summarized by study arm.