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CBDV vs placebo hos børn og voksne op til 30 år med Prader-Willi syndrom (PWS)

16. april 2026 opdateret af: Eric Hollander

Cannabidivarin (CBDV) vs. placebo hos børn og voksne op til 30 år med Prader-Willi syndrom (PWS)

Dette forsøg har til formål at undersøge effektiviteten og sikkerheden af ​​cannabidivarin (CBDV) som behandling for børn med PWS.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette kliniske forskningsforsøg har til formål at studere effektiviteten og sikkerheden af ​​cannabidivarin (CBDV), en naturligt forekommende homolog af phytocannabinoid cannabidiol (CBD) hos børn og unge voksne med Prader-Willi Syndrom (PWS). CBDV har virkninger uafhængige af CB1- og CB2-receptoraktivering og en god sikkerhedsprofil. Dette forslag henvender sig til Fonden for Prader Willi Researchs femårige PWS-forskningsplan: Program 1, Clinical Care Research: søger at evaluere behandlinger, der har til formål at reducere adfærdssymptomer, såsom irritabilitet, for at forbedre livskvaliteten for både individet med PWS og deres familier. GW Pharmaceuticals vil levere CBDV-lægemidlet og matchende placebo og yderligere finansiering til webstedet.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center, Albert Einstein College of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 30 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier

  1. Mandlige eller kvindelige ambulante patienter i alderen 5 til 30 år.
  2. Diagnose af PWS bekræftet ved genetisk testning og patientjournaler og historie.
  3. Stabile farmakologiske, uddannelsesmæssige, adfærdsmæssige og/eller diætinterventioner i 4 uger før studiestart og i hele undersøgelsens varighed.
  4. Få en fysisk undersøgelse og laboratorieresultater, der er inden for normerne for PWS
  5. Tilstedeværelse af en forælder/plejer/værge, der er i stand til at give samtykke til deres deltagelse og gennemføre vurderinger vedrørende patientens udvikling og adfærd gennem hele undersøgelsen. Samtykke fra børn vil blive opnået, hvis forsøgspersonen er 7 år eller ældre og har den mentale evne til at forstå og underskrive en skriftlig samtykkeerklæring og/eller give mundtlig samtykke.
  6. Score på Clinical Global Impression Scale Severity (CGI-S) ≥ 4 (moderat sværhedsgrad) ved baseline.
  7. Score på ≥18 på afvigende adfærdstjekliste-irritabilitet (ABC-I) ved baseline.
  8. Accepter ikke at køre bil eller betjene maskiner.

Eksklusionskriterier

  1. Eksponering for ethvert forsøgsmiddel i de 30 dage før randomisering.
  2. Forudgående kronisk behandling med CBD eller CBDV.
  3. Positiv test for THC eller andre misbrugsstoffer via urintest ved screeningbesøget eller baselinebesøg ved gentagen bekræftelsestest.
  4. Historie om stofmisbrugsforstyrrelser inklusive cannabisbrugsforstyrrelse
  5. En anden primær psykiatrisk diagnose end PWS, herunder bipolar lidelse, psykose, skizofreni, PTSD eller MDD. Disse patienter vil blive udelukket på grund af potentielle forvirrende resultater.
  6. En medicinsk tilstand, der i alvorlig grad påvirker forsøgspersonens evne til at deltage i undersøgelsen, forstyrrer udførelsen af ​​undersøgelsen, forvirrer fortolkningen af ​​undersøgelsesresultater eller bringer forsøgspersonens velbefindende i fare (herunder, men ikke begrænset til, nedsat lever- eller nyrefunktion og hjerte-kar-sygdomme).
  7. Kendt eller mistænkt allergi over for CBDV eller hjælpestoffer anvendt i formuleringen (dvs. sesam).
  8. Kliniske indikationer på nyre-, bugspytkirtel- eller hæmatologisk dysfunktion som påvist af værdier over øvre normalgrænser for BUN/kreatinin, værdier to gange den øvre grænse for normal for serumlipase og amylase, blodplader
  9. EKG-abnormitet ved baseline-screening eller klinisk signifikant posturalt fald i systolisk blodtryk ved screening. Hvis det indledende screenings-EKG viser en QTcB på mere end 460 msek, vil der blive udført 2 yderligere EKG'er i samme møde med 5 minutters mellemrum. Hvis det ikke genkendes ved screening, så en fuld tredobbelt gentagelse, der viser en gennemsnitlig QTcB på 460 msek eller mindre for at opfylde alle inklusions-/eksklusionskriterier
  10. Kvindelige forsøgspersoner, der er gravide, vil blive udelukket fra undersøgelsen. Hvis en kvindelig forsøgsperson er i stand til at blive gravid, vil hun få en graviditetstest, før hun går ind i undersøgelsen. Kvindelige forsøgspersoner vil blive informeret om ikke at blive gravide, mens de tager CBDV. Kvindelige forsøgspersoner skal fortælle investigatoren og konsultere en fødselslæge eller specialist hos moder-føtal, hvis de bliver gravide under undersøgelsen.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cannabidivarin (CBDV)
Vægtbaseret dosering på 10 mg/kg/dag af CBDV i 12 uger
Medicin: CBDV Compound
CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC).
Placebo komparator: Matchet placebo
Vægtbaseret dosering på 10 mg/kg/dag placebo i 12 uger
Medicin: Placebo
Placebo oral opløsning indeholder matchende hjælpestoffer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Irritability Based on Aberrant Behavior Checklist-Irritability (ABC-I) Subscale
Tidsramme: 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.
Baseline, Week 4, Week 8, Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Repetitive Behavior Based on the Repetitive Behavior Scale-Revised (RBS-R).
Tidsramme: 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.
Baseline, Week 4, Week 8, Week 12
Repetitive Behaviors Based on Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Tidsramme: 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.
Baseline, Week 4, Week 8, Week 12
Hyperphagia
Tidsramme: 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.
Baseline, Week 4, Week 8, Week 12
Global Functioning
Tidsramme: 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.
Week 4, Week 8, Week 12
Caregiver Strain
Tidsramme: 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.
Baseline, Week 4, Week 8, Week 12
Rigid Behavior - Based on the Montefiore-Einstein Rigidity Scale-Revised-Prader-Willi Syndrome Scale (MERS-R-PWS)
Tidsramme: 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.
Week 12
Aberrant Behavior
Tidsramme: 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.
Baseline, Week 4, Week 8, Week 12
Sleep Quality
Tidsramme: 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.
Baseline through Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eric Hollander

Samarbejdspartnere

Foundation for Prader-Willi Research
GW Pharmaceuticals Ltd

Efterforskere

  • Ledende efterforsker: Eric Hollander, MD, Montefiore Medical Center/Albert Einstein College of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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  • Angulo MA, Butler MG, Cataletto ME. Prader-Willi syndrome: a review of clinical, genetic, and endocrine findings. J Endocrinol Invest. 2015;38(12):1249-1263.
  • Miller J, Wagner M. Prader-Willi syndrome and sleep-disordered breathing. Pediatr Ann. 2013;42(10):200-204.
  • 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;167A(3):563-571.
  • Viardot A, Sze L, Purtell L, et al. Prader-Willi syndrome is associated with activation of the innate immune system independently of central adiposity and insulin resistance. J Clin Endocrinol Metab. 2010;95(7):3392-3399.
  • Irizarry KA, Miller M, Freemark M, Haqq AM. Prader Willi Syndrome: Genetics, Metabolomics, Hormonal Function, and New Approaches to Therapy. Adv Pediatr. 2016;63(1):47-77.
  • Rout U, Abdul-Rahman OA, Dhossche DM. An immunological basis of hyperphagia driven by GABAergic dysfunction in Prader-Willi Syndrome. Med Hypotheses. 2012;78(4):462-464.
  • Knuesel I, Chicha L, Britschgi M, et al. Maternal immune activation and abnormal brain development across CNS disorders. Nat Rev Neurol. 2014;10(11):643-660.
  • Blackmon K. Structural MRI biomarkers of shared pathogenesis in autism spectrum disorder and epilepsy. Epilepsy Behav. 2015;47:172-182.
  • Washington J, 3rd, Kumar U, Medel-Matus JS, Shin D, Sankar R, Mazarati A. Cytokinedependent bidirectional connection between impaired social behavior and susceptibility to seizures associated with maternal immune activation in mice. Epilepsy Behav. 2015;50:40- 45.
  • Basavarajappa BS, Nixon RA, Arancio O. Endocannabinoid system: emerging role from neurodevelopment to neurodegeneration. Mini Rev Med Chem. 2009;9(4):448-462.
  • 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;249:124-132.
  • Klein TW, Cabral GA. Cannabinoid-induced immune suppression and modulation of antigen-presenting cells. J Neuroimmune Pharmacol. 2006;1(1):50-64.
  • Devinsky O, Cilio MR, Cross H, et al. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia. 2014;55(6):791-802.
  • 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;11:78.
  • Jean-Gilles L, Gran B, Constantinescu CS. Interaction between cytokines, cannabinoids and the nervous system. Immunobiology. 2010;215(8):606-610.
  • Anavi-Goffer S, Baillie G, Irving AJ, et al. Modulation of L-alpha-lysophosphatidylinositol/GPR55 mitogen-activated protein kinase (MAPK) signaling by cannabinoids. J Biol Chem. 2012;287(1):91-104.
  • 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;170(3):671-678.
  • Pagano E, Romano B, Iannotti FA, et al. The non-euphoric phytocannabinoid cannabidivarin counteracts intestinal inflammation in mice and cytokine expression in biopsies from UC pediatric patients. Pharmacol Res. 2019;149:104464.
  • De Petrocellis L, Ligresti A, Moriello AS, et al. Effects of cannabinoids and cannabinoidenriched Cannabis extracts on TRP channels and endocannabinoid metabolic enzymes. Br J Pharmacol. 2011;163(7):1479-1494.
  • Deiana S, Watanabe A, Yamasaki Y, et al. 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;219(3):859-873.
  • Olah A, Markovics A, Szabo-Papp J, et al. Differential effectiveness of selected nonpsychotropic phytocannabinoids on human sebocyte functions implicates their introduction in dry/seborrhoeic skin and acne treatment. Exp Dermatol. 2016;25(9):701-707.
  • Coiro P, Padmashri R, Suresh A, et al. Impaired synaptic development in a maternal immune activation mouse model of neurodevelopmental disorders. Brain Behav Immun. 2015;50:249-258.
  • Uzunova G, Pallanti S, Hollander E. Excitatory/inhibitory imbalance in autism spectrum disorders: Implications for interventions and therapeutics. World J Biol Psychiatry. 2016;17(3):174-186.
  • Hill AJ, Mercier MS, Hill TD, et al. Cannabidivarin is anticonvulsant in mouse and rat. Br J Pharmacol. 2012;167(8):1629-1642.
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  • 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;98(2):268-272.
  • Kuo HY, Liu FC. Molecular Pathology and Pharmacological Treatment of Autism Spectrum Disorder-Like Phenotypes Using Rodent Models. Front Cell Neurosci. 2018;12:422.
  • McCracken JT, McGough J, Shah B, et al. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002;347(5):314-321.
  • Marcus RN, Owen R, Kamen L, et al. 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;48(11):1110-1119.
  • Lam KS, Aman MG. The Repetitive Behavior Scale-Revised: independent validation in individuals with autism spectrum disorders. J Autism Dev Disord. 2007;37(5):855-866.
  • Schertz HH, Odom SL, Baggett KM, Sideris JH. Parent-Reported Repetitive Behavior in Toddlers on the Autism Spectrum. J Autism Dev Disord. 2016;46(10):3308-3316.
  • 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;46(8):2813-2820.
  • Goodman WK, Price LH, Rasmussen SA, et al. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989;46(11):1006-1011.
  • McCandless SE, Yanovski JA, Miller J, et al. Effects of MetAP2 inhibition on hyperphagia and body weight in Prader-Willi syndrome: A randomized, double-blind, placebocontrolled trial. Diabetes Obes Metab. 2017;19(12):1751-1761.
  • 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;8(8):e72406.
  • 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;19(6):736745.
  • Roid GB, R. . Essentials of Stanford-Binet Intelligence Scales (SB5) Assessment. Hoboken, New Jersey: John Wiley & Sons, Inc; 2004.
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  • Al Saabi A, Allorge D, Sauvage FL, et al. Involvement of UDP-glucuronosyltransferases UGT1A9 and UGT2B7 in ethanol glucuronidation, and interactions with common drugs of abuse. Drug Metab Dispos. 2013;41(3):568-574.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. november 2020

Primær færdiggørelse (Faktiske)

31. oktober 2024

Studieafslutning (Faktiske)

31. oktober 2024

Datoer for studieregistrering

Først indsendt

19. februar 2019

Først indsendt, der opfyldte QC-kriterier

19. februar 2019

Først opslået (Faktiske)

20. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019-9914

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Al IPD, der ligger til grund, resulterer i en publikation

IPD-delingstidsramme

Following publication for an indefinite period.

IPD-delingsadgangskriterier

Contact Principal Investigator for availability of IPD data.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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