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Only limited funding was available and the study was never able to be conducted to its natural conclusion.
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| Name | Class |
|---|---|
| Foundation for Prader-Willi Research | OTHER |
| GW Pharmaceuticals Ltd | INDUSTRY |
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This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidivarin (CBDV) | Experimental | Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks |
|
| Matched Placebo | Placebo Comparator | Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBDV Compound | Drug | CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Irritability Based on Aberrant Behavior Checklist-Irritability (ABC-I) Subscale | 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. | Baseline, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Repetitive Behavior Based on the Repetitive Behavior Scale-Revised (RBS-R). | 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hollander, MD | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center, Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26022164 | Background | Kalsner L, Chamberlain SJ. Prader-Willi, Angelman, and 15q11-q13 Duplication Syndromes. Pediatr Clin North Am. 2015 Jun;62(3):587-606. doi: 10.1016/j.pcl.2015.03.004. Epub 2015 Apr 22. | |
| 26062517 | Background | Angulo MA, Butler MG, Cataletto ME. Prader-Willi syndrome: a review of clinical, genetic, and endocrine findings. J Endocrinol Invest. 2015 Dec;38(12):1249-63. doi: 10.1007/s40618-015-0312-9. Epub 2015 Jun 11. |
| Label | URL |
|---|---|
| Research FfP-W. PWS Research Plan 2017-2021. 2017 | View source |
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All IPD that underlie results in a publication
Following publication for an indefinite period.
Contact Principal Investigator for availability of IPD data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabidivarin (CBDV) | Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks Cannabidivarin (CBDV) Compound: CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC) |
| FG001 | Matched Placebo | Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks Placebo: Placebo oral solution contains matching excipients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabidivarin (CBDV) | Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks CBDV Compound: CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of THC |
| BG001 | Matched Placebo |
| 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 |
| 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 | Irritability Based on Aberrant Behavior Checklist-Irritability (ABC-I) Subscale | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 8, Week 12 |
|
Adverse event data was collected during the baseline visit (onsite), Week 2 (remote), Week 4 (remote), Week 6 (remote), Week 8 (remote), Week 10 (remote), Week 12 (or early termination) (onsite), and during a Week 14 follow-up call (remote). Up to 14 weeks overall.
Information about all adverse events (AEs), whether volunteered by the subject, discovered by the principal investigator or study coordinator, or detected through physical examination, laboratory test, or other means, will be collected, recorded and repeated/followed as appropriate.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cannabidivarin (CBDV) | Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks CBDV Compound: CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of THC |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissociative Symptoms | General disorders | Non-systematic Assessment |
The study was terminated early and powered statistical analyses were not conducted with exception of effect size determinations for the MERS-R-PWS outcome measure notwithstanding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Hollander | Albert Einstein College of Medicine | 718-839-7516 | Eholland@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2022 | Mar 18, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2024 | Mar 20, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C580853 | cannabidivarin |
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| Placebo | Drug | Placebo oral solution contains matching excipients. |
|
| Baseline, Week 4, Week 8, Week 12 |
| Repetitive Behaviors Based on Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | 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. | Baseline, Week 4, Week 8, Week 12 |
| Hyperphagia | 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. | Baseline, Week 4, Week 8, Week 12 |
| Global Functioning | 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. | Week 4, Week 8, Week 12 |
| Caregiver Strain | 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. | Baseline, Week 4, Week 8, Week 12 |
| Rigid Behavior - Based on the Montefiore-Einstein Rigidity Scale-Revised-Prader-Willi Syndrome Scale (MERS-R-PWS) | 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. | Week 12 |
| Aberrant Behavior | 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. | Baseline, Week 4, Week 8, Week 12 |
| Sleep Quality | 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. | Baseline through Week 12 |
| 24126982 | Background | Miller J, Wagner M. Prader-Willi syndrome and sleep-disordered breathing. Pediatr Ann. 2013 Oct;42(10):200-4. doi: 10.3928/00904481-20130924-10. |
| 25691409 | Background | Butler MG, Hossain W, Sulsona C, Driscoll DJ, Manzardo AM. Increased plasma chemokine levels in children with Prader-Willi syndrome. Am J Med Genet A. 2015 Mar;167A(3):563-71. doi: 10.1002/ajmg.a.36908. |
| 20444923 | Background | Viardot A, Sze L, Purtell L, Sainsbury A, Loughnan G, Smith E, Herzog H, Steinbeck K, Campbell LV. Prader-Willi syndrome is associated with activation of the innate immune system independently of central adiposity and insulin resistance. J Clin Endocrinol Metab. 2010 Jul;95(7):3392-9. doi: 10.1210/jc.2009-2492. Epub 2010 May 5. |
| 27426895 | Background | Irizarry KA, Miller M, Freemark M, Haqq AM. Prader Willi Syndrome: Genetics, Metabolomics, Hormonal Function, and New Approaches to Therapy. Adv Pediatr. 2016 Aug;63(1):47-77. doi: 10.1016/j.yapd.2016.04.005. No abstract available. |
| 22289342 | Background | Rout U, Abdul-Rahman OA, Dhossche DM. An immunological basis of hyperphagia driven by GABAergic dysfunction in Prader-Willi Syndrome. Med Hypotheses. 2012 Apr;78(4):462-4. doi: 10.1016/j.mehy.2011.12.020. Epub 2012 Jan 30. |
| 25311587 | Background | Knuesel I, Chicha L, Britschgi M, Schobel SA, Bodmer M, Hellings JA, Toovey S, Prinssen EP. Maternal immune activation and abnormal brain development across CNS disorders. Nat Rev Neurol. 2014 Nov;10(11):643-60. doi: 10.1038/nrneurol.2014.187. Epub 2014 Oct 14. |
| 25812936 | Background | Blackmon K. Structural MRI biomarkers of shared pathogenesis in autism spectrum disorder and epilepsy. Epilepsy Behav. 2015 Jun;47:172-82. doi: 10.1016/j.yebeh.2015.02.017. Epub 2015 Mar 24. |
| 26103532 | Background | Washington J 3rd, Kumar U, Medel-Matus JS, Shin D, Sankar R, Mazarati A. Cytokine-dependent bidirectional connection between impaired social behavior and susceptibility to seizures associated with maternal immune activation in mice. Epilepsy Behav. 2015 Sep;50:40-5. doi: 10.1016/j.yebeh.2015.05.040. Epub 2015 Jun 21. |
| 19356123 | Background | Basavarajappa BS, Nixon RA, Arancio O. Endocannabinoid system: emerging role from neurodevelopment to neurodegeneration. Mini Rev Med Chem. 2009 Apr;9(4):448-62. doi: 10.2174/138955709787847921. |
| 23643692 | Background | Kerr DM, Downey L, Conboy M, Finn DP, Roche M. Alterations in the endocannabinoid system in the rat valproic acid model of autism. Behav Brain Res. 2013 Jul 15;249:124-32. doi: 10.1016/j.bbr.2013.04.043. Epub 2013 May 1. |
| 18040791 | Background | Klein TW, Cabral GA. Cannabinoid-induced immune suppression and modulation of antigen-presenting cells. J Neuroimmune Pharmacol. 2006 Mar;1(1):50-64. doi: 10.1007/s11481-005-9007-x. |
| 24854329 | Background | Devinsky O, Cilio MR, Cross H, Fernandez-Ruiz J, French J, Hill C, Katz R, Di Marzo V, Jutras-Aswad D, Notcutt WG, Martinez-Orgado J, Robson PJ, Rohrback BG, Thiele E, Whalley B, Friedman D. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia. 2014 Jun;55(6):791-802. doi: 10.1111/epi.12631. Epub 2014 May 22. |
| 24739187 | Background | Siniscalco D, Bradstreet JJ, Cirillo A, Antonucci N. The in vitro GcMAF effects on endocannabinoid system transcriptionomics, receptor formation, and cell activity of autism-derived macrophages. J Neuroinflammation. 2014 Apr 17;11:78. doi: 10.1186/1742-2094-11-78. |
| 20153076 | Background | Jean-Gilles L, Gran B, Constantinescu CS. Interaction between cytokines, cannabinoids and the nervous system. Immunobiology. 2010 Aug;215(8):606-10. doi: 10.1016/j.imbio.2009.12.006. Epub 2010 Jan 4. |
| 22027819 | Background | Anavi-Goffer S, Baillie G, Irving AJ, Gertsch J, Greig IR, Pertwee RG, Ross RA. Modulation of L-alpha-lysophosphatidylinositol/GPR55 mitogen-activated protein kinase (MAPK) signaling by cannabinoids. J Biol Chem. 2012 Jan 2;287(1):91-104. doi: 10.1074/jbc.M111.296020. Epub 2011 Oct 25. |
| 23902479 | Background | Rock EM, Sticht MA, Duncan M, Stott C, Parker LA. Evaluation of the potential of the phytocannabinoids, cannabidivarin (CBDV) and Delta(9) -tetrahydrocannabivarin (THCV), to produce CB1 receptor inverse agonism symptoms of nausea in rats. Br J Pharmacol. 2013 Oct;170(3):671-8. doi: 10.1111/bph.12322. |
| 31553934 | Background | Pagano E, Romano B, Iannotti FA, Parisi OA, D'Armiento M, Pignatiello S, Coretti L, Lucafo M, Venneri T, Stocco G, Lembo F, Orlando P, Capasso R, Di Marzo V, Izzo AA, Borrelli F. The non-euphoric phytocannabinoid cannabidivarin counteracts intestinal inflammation in mice and cytokine expression in biopsies from UC pediatric patients. Pharmacol Res. 2019 Nov;149:104464. doi: 10.1016/j.phrs.2019.104464. Epub 2019 Sep 22. |
| 21175579 | Background | De Petrocellis L, Ligresti A, Moriello AS, Allara M, Bisogno T, Petrosino S, Stott CG, Di Marzo V. Effects of cannabinoids and cannabinoid-enriched Cannabis extracts on TRP channels and endocannabinoid metabolic enzymes. Br J Pharmacol. 2011 Aug;163(7):1479-94. doi: 10.1111/j.1476-5381.2010.01166.x. |
| 21796370 | Background | Deiana S, Watanabe A, Yamasaki Y, Amada N, Arthur M, Fleming S, Woodcock H, Dorward P, Pigliacampo B, Close S, Platt B, Riedel G. Plasma and brain pharmacokinetic profile of cannabidiol (CBD), cannabidivarine (CBDV), Delta(9)-tetrahydrocannabivarin (THCV) and cannabigerol (CBG) in rats and mice following oral and intraperitoneal administration and CBD action on obsessive-compulsive behaviour. Psychopharmacology (Berl). 2012 Feb;219(3):859-73. doi: 10.1007/s00213-011-2415-0. Epub 2011 Jul 28. |
| 27094344 | Background | Olah A, Markovics A, Szabo-Papp J, Szabo PT, Stott C, Zouboulis CC, Biro T. Differential effectiveness of selected non-psychotropic phytocannabinoids on human sebocyte functions implicates their introduction in dry/seborrhoeic skin and acne treatment. Exp Dermatol. 2016 Sep;25(9):701-7. doi: 10.1111/exd.13042. Epub 2016 Jun 15. |
| 26218293 | Background | Coiro P, Padmashri R, Suresh A, Spartz E, Pendyala G, Chou S, Jung Y, Meays B, Roy S, Gautam N, Alnouti Y, Li M, Dunaevsky A. Impaired synaptic development in a maternal immune activation mouse model of neurodevelopmental disorders. Brain Behav Immun. 2015 Nov;50:249-258. doi: 10.1016/j.bbi.2015.07.022. Epub 2015 Jul 26. |
| 26469219 | Background | Uzunova G, Pallanti S, Hollander E. Excitatory/inhibitory imbalance in autism spectrum disorders: Implications for interventions and therapeutics. World J Biol Psychiatry. 2016 Apr;17(3):174-86. doi: 10.3109/15622975.2015.1085597. Epub 2015 Oct 15. |
| 22970845 | Background | Hill AJ, Mercier MS, Hill TD, Glyn SE, Jones NA, Yamasaki Y, Futamura T, Duncan M, Stott CG, Stephens GJ, Williams CM, Whalley BJ. Cannabidivarin is anticonvulsant in mouse and rat. Br J Pharmacol. 2012 Dec;167(8):1629-42. doi: 10.1111/j.1476-5381.2012.02207.x. |
| 23902406 | Background | Hill TD, Cascio MG, Romano B, Duncan M, Pertwee RG, Williams CM, Whalley BJ, Hill AJ. Cannabidivarin-rich cannabis extracts are anticonvulsant in mouse and rat via a CB1 receptor-independent mechanism. Br J Pharmacol. 2013 Oct;170(3):679-92. doi: 10.1111/bph.12321. |
| 25703248 | Background | Burstein S. Cannabidiol (CBD) and its analogs: a review of their effects on inflammation. Bioorg Med Chem. 2015 Apr 1;23(7):1377-85. doi: 10.1016/j.bmc.2015.01.059. Epub 2015 Feb 7. |
| 24851090 | Background | Murillo-Rodriguez E, Sarro-Ramirez A, Sanchez D, Mijangos-Moreno S, Tejeda-Padron A, Poot-Ake A, Guzman K, Pacheco-Pantoja E, Arias-Carrion O. Potential effects of cannabidiol as a wake-promoting agent. Curr Neuropharmacol. 2014 May;12(3):269-72. doi: 10.2174/1570159X11666131204235805. |
| 21238476 | Background | Scopinho AA, Guimaraes FS, Correa FM, Resstel LB. Cannabidiol inhibits the hyperphagia induced by cannabinoid-1 or serotonin-1A receptor agonists. Pharmacol Biochem Behav. 2011 Apr;98(2):268-72. doi: 10.1016/j.pbb.2011.01.007. Epub 2011 Jan 14. |
| 30524240 | Background | Kuo HY, Liu FC. Molecular Pathology and Pharmacological Treatment of Autism Spectrum Disorder-Like Phenotypes Using Rodent Models. Front Cell Neurosci. 2018 Nov 20;12:422. doi: 10.3389/fncel.2018.00422. eCollection 2018. |
| 12151468 | Background | McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG, Arnold LE, Lindsay R, Nash P, Hollway J, McDougle CJ, Posey D, Swiezy N, Kohn A, Scahill L, Martin A, Koenig K, Volkmar F, Carroll D, Lancor A, Tierney E, Ghuman J, Gonzalez NM, Grados M, Vitiello B, Ritz L, Davies M, Robinson J, McMahon D; Research Units on Pediatric Psychopharmacology Autism Network. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug 1;347(5):314-21. doi: 10.1056/NEJMoa013171. |
| 19797985 | Background | Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658. |
| 17048092 | Background | Lam KS, Aman MG. The Repetitive Behavior Scale-Revised: independent validation in individuals with autism spectrum disorders. J Autism Dev Disord. 2007 May;37(5):855-66. doi: 10.1007/s10803-006-0213-z. |
| 27460002 | Background | Schertz HH, Odom SL, Baggett KM, Sideris JH. Parent-Reported Repetitive Behavior in Toddlers on the Autism Spectrum. J Autism Dev Disord. 2016 Oct;46(10):3308-16. doi: 10.1007/s10803-016-2870-x. |
| 27230762 | Background | Ventola PE, Yang D, Abdullahi SM, Paisley CA, Braconnier ML, Sukhodolsky DG. Brief Report: Reduced Restricted and Repetitive Behaviors after Pivotal Response Treatment. J Autism Dev Disord. 2016 Aug;46(8):2813-2820. doi: 10.1007/s10803-016-2813-6. |
| 2684084 | Background | Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007. |
| 28556449 | Background | McCandless SE, Yanovski JA, Miller J, Fu C, Bird LM, Salehi P, Chan CL, Stafford D, Abuzzahab MJ, Viskochil D, Barlow SE, Angulo M, Myers SE, Whitman BY, Styne D, Roof E, Dykens EM, Scheimann AO, Malloy J, Zhuang D, Taylor K, Hughes TE, Kim DD, Butler MG. Effects of MetAP2 inhibition on hyperphagia and body weight in Prader-Willi syndrome: A randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Dec;19(12):1751-1761. doi: 10.1111/dom.13021. Epub 2017 Jul 13. |
| 23951321 | Background | Arora T, Broglia E, Pushpakumar D, Lodhi T, Taheri S. An investigation into the strength of the association and agreement levels between subjective and objective sleep duration in adolescents. PLoS One. 2013 Aug 9;8(8):e72406. doi: 10.1371/journal.pone.0072406. eCollection 2013. |
| 25398894 | Background | Baum KT, Shear PK, Howe SR, Bishop SL. A comparison of WISC-IV and SB-5 intelligence scores in adolescents with autism spectrum disorder. Autism. 2015 Aug;19(6):736-45. doi: 10.1177/1362361314554920. Epub 2014 Nov 14. |
| Background | Roid GB, R. . Essentials of Stanford-Binet Intelligence Scales (SB5) Assessment. Hoboken, New Jersey: John Wiley & Sons, Inc; 2004. |
| 31762487 | Background | Luther K, Fung GM, Khorassani F. Cost Comparison of Atypical Antipsychotics: Paliperidone ER and Risperidone. Hosp Pharm. 2019 Dec;54(6):389-392. doi: 10.1177/0018578718809269. Epub 2018 Nov 4. |
| 23230132 | Background | Al Saabi A, Allorge D, Sauvage FL, Tournel G, Gaulier JM, Marquet P, Picard N. Involvement of UDP-glucuronosyltransferases UGT1A9 and UGT2B7 in ethanol glucuronidation, and interactions with common drugs of abuse. Drug Metab Dispos. 2013 Mar;41(3):568-74. doi: 10.1124/dmd.112.047878. Epub 2012 Dec 10. |
Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks
Placebo: Placebo oral solution contains matching excipients.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Irritability Based on Aberrant Behavior Checklist-Irritability Subscale (ABC-I) | Irritability at baseline was assessed using the ABC-I subscale, 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. | Mean | Standard Deviation | score on a scale |
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| Repetitive Behavior based on the Repetitive Behavior Scale-Revised (RBS-R) | Repetitive behavior will be evaluated using RBS-R, a 43-item self-report questionnaire used to measure the breadth or repetitive behaviors in children/adolescents/adults with Autism Spectrum Disorder (ASD). RBS-R consists of 6 behavior subscales: Stereotyped; Self-injurious; Compulsive; Ritualistic; Sameness; and Restricted Behavior. Each item is rated on a 4-point Likert scale 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. | Mean | Standard Deviation | score on a scale |
|
| Obsessive Compulsive based on the Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS) | Obsessive-compulsive symptoms at baseline were assessed using the CY-BOCS. CY-BOCS is a 10-item clinician-rated measure designed to assess the severity of obsessive-compulsive symptoms in participants 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. | Mean | Standard Deviation | score on a scale |
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| Hyperphagia based on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Hyperphagia was assessed at baseline 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. | Mean | Standard Deviation | score on a scale |
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| Caregiver Strain based on the Caregiver Strain Questionnaire (CSQ) | Caregiver strain was Assessed using the CSQ, a 21-item self-report questionnaire, consisting of 3 subscales, Objective Strain, Subjective Externalized Strain and Subjective Internalized Strain, developed to assess caregiver strain/stress for families with a child living with an emotional or behavioral disorder. CSQ items are rated from 1 ("Not at all a problem") to 5 ("Very much a problem"). Global Scores are calculated by averaging items within each subscale and summing the 3 subscale means for a total scale range of 3-15. Higher Global Scores are associated with increased Caregiver Strain. | Mean | Standard Deviation | score on a scale |
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| Rigid Behavior - Montefiore Einstein Rigidity Scale-Revised-Prader-Willi Syndrome (MERS-R-PWS) | Rigid behavior at baseline was assessed using the MERS-R-PWS, a clinician-rated scale designed to assess 3 domains of rigid behavior in individuals with PWS: Behavioral (Insistence on sameness, things must be done his/her way); Cognitive (Special interests, inflexible adherence to rules); and Protest (in response to deviation from rigidity; e.g., tantrum, irritability, arguing). Each domain consists of 4 items rated on a 5-point scale from 0 ("No/None/Not difficult") to 4 ("Extreme/Extremely difficult"), for an overall range of 0-48. Higher scores are indicative of greater overall rigidity. | Mean | Standard Deviation | score on a scale |
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| Behavioral Rigidity based on the MERS - Behavioral Rigidity domain subscale | Behavioral rigidity (e.g., Insistence on sameness, things must be done in his/her way, etc.) at baseline was assessed using the MERS-R-PWS behavioral rigidity subscale. The MERS-R-PWS is a clinician-rated scale designed to assess 3 domains of rigid behavior in individuals with PWS. The behavioral rigidity 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. Higher scores are indicative of greater behavioral rigidity. | Mean | Standard Deviation | score on a scale |
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| Cognitive Rigidity based on the MERS - Cognitive Rigidity domain subscale | Cognitive rigidity (e.g., Special interests, inflexible adherence to rules, etc.) at baseline was assessed using the MERS-R-PWS cognitive rigidity subscale. The MERS-R-PWS is a clinician-rated scale designed to assess 3 domains of rigid behavior in individuals with PWS. The cognitive rigidity 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. Higher scores are indicative of greater cognitive rigidity. | Mean | Standard Deviation | score on a scale |
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| Protest behavior based on the MERS - Protest Domain subscale | Protest behavior (in response to deviation from rigidity; e.g., tantrum, irritability, arguing) at baseline was assessed based using the protest domain subscale of 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. The protest behavior 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. Higher scores are indicative of greater protest behavior. | Mean | Standard Deviation | score on a scale |
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| Aberrant Behavior - Aberrant Behavior Checklist (ABC) | Aberrant Behavior was assessed using the ABC, a 58-item rating instrument, completed by a caregiver, used to measure maladaptive behaviors in individuals with developmental disabilities and ASD. ABC resolves into 5 subscales: Irritability; Lethargy/Social withdrawal; Stereotypic behavior; Hyperactivity/noncompliance; Inappropriate speech. ABC measures behavior on a 4-point severity scale from 0 ("Not all a problem") to 3 ("Severe problem"). Overall score is calculated by summing all items (overall possible range 0-174.) Higher scores indicate greater overall severity of maladaptive behaviors. | Mean | Standard Deviation | score on a scale |
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| Lethargy/Social withdrawal based on the ABC-Lethargy-Social Withdrawal subscale | Lethargy/Social withdrawal at baseline was assessed using the ABC-Lethargy/Social withdrawal subscale of the ABC scale. The ABC is a 58-item rating instrument, completed by a caregiver, used to measure maladaptive behaviors in individuals with developmental disabilities. One subscale is the Lethargy/Social withdrawal subscale. This consists of 16 items which measure behavior on a 4-point Likert scale from 0 ("Not all a problem") to 3 ("Severe problem"), yielding an overall subscale score of 0-48, such that higher scores are indicative of greater overall severity of these withdrawal behaviors. | Mean | Standard Deviation | score on a scale |
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| Stereotypic behavior based on the ABC-Stereotypic Behavior subscale | Stereotypic behavior at baseline was assessed using the ABC-Stereotypic behavior subscale of the ABC scale. The ABC is a 58-item rating instrument, completed by a caregiver, used to measure maladaptive behaviors in individuals with developmental disabilities. One of the subscales is the Stereotypic behavior subscale. This domain consists of 7 items which measure behavior on a 4-point Likert scale from 0 ("Not all a problem") to 3 ("Severe problem"), yielding an overall subscale score of 0-21, such that higher scores are indicative of greater overall severity of Stereotypic behaviors. | Mean | Standard Deviation | score on a scale |
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| Hyperactivity/Noncompliance based on the ABC-Hyperactivity subscale | Hyperactivity/Noncompliance at baseline was assessed using the ABC-Hyperactivity subscale of the ABC scale. The ABC is a 58-item rating instrument, completed by a caregiver, used to measure maladaptive behaviors in individuals with developmental disabilities. One of the subscales is the Hyperactivity/Noncompliance subscale. This domain consists of 16 items which measure behavior on a 4-point Likert scale from 0 ("Not all a problem") to 3 ("Severe problem"), yielding an overall subscale score of 0-48, such that higher scores are indicative of greater overall severity of hyperactive behaviors. | Mean | Standard Deviation | score on a scale |
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| Inappropriate Speech based on the ABC-Inappropriate Speech subscale | Inappropriate speech at baseline was assessed using the ABC-Inappropriate speech subscale of the ABC scale. The ABC is a 58-item rating instrument, completed by a caregiver, used to measure maladaptive behaviors in individuals with developmental disabilities. One of the subscales is the Inappropriate speech subscale. This domain consists of 4 items which measure behavior on a 4-point Likert scale from 0 ("Not all a problem") to 3 ("Severe problem"), yielding an overall subscale score of 0-12, such that higher scores are indicative of greater overall severity of inappropriate speech behaviors. | Mean | Standard Deviation | score on a scale |
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| Cannabidivarin (CBDV) |
Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks CBDV Compound: CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of THC |
| OG001 | Matched Placebo | Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks Placebo: Placebo oral solution contains matching excipients. |
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| Secondary | Repetitive Behavior Based on the Repetitive Behavior Scale-Revised (RBS-R). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Repetitive Behaviors Based on Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | 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. | Data was missing from one of the participants in the CBDV arm/group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Hyperphagia | 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. | Hyperphagia data was available for all Week 4 participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Global Functioning | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 4, Week 8, Week 12 |
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| Secondary | Caregiver Strain | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Rigid Behavior - Based on the Montefiore-Einstein Rigidity Scale-Revised-Prader-Willi Syndrome Scale (MERS-R-PWS) | 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. | Full week 12 scores were available for the CBDV arm for this outcome measure as data was imputed. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Aberrant Behavior | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Sleep Quality | 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. | 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. | Posted | Baseline through Week 12 |
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| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Matched Placebo | Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks Placebo: Placebo oral solution contains matching excipients. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| MERS-R-PWS Cognitive Rigidity |
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| MERS-R-PWS-Protest |
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| Effect Size (cohen's d) |
| 2.40 |
| 2-Sided |
| Other |
Cohen's d for CBDV vs. Placebo change in score on MERS-R-PWS Behavioral Rigidity Subscale. |
| Effect Size (cohen's d) | 1.68 | 2-Sided | Other | Cohen's d for CBDV vs. Placebo change in score on MERS-R-PWS Cognitive Rigidity Subscale |
| Effect Size (cohen's d) | 2.19 | 2-Sided | Other | Cohen's d for CBDV vs. Placebo change in score on MERS-R-PWS Protest Subscale |
| Lethargy/Social withdrawal - Week 12 |
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| Stereotypic behavior - Week 4 |
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| Stereotypic behavior - Week 8 |
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| Stereotypic behavior - Week 12 |
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| Hyperactivity/noncompliance - Week 4 |
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| Hyperactivity/noncompliance - Week 8 |
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| Hyperactivity/noncompliance - Week 12 |
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| Inappropriate speech - Week 4 |
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| Inappropriate speech - Week 8 |
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| Inappropriate speech - Week 12 |
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