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En prospektiv, multisenter, randomisert kontrollert blindforsøk som demonstrerer sikkerheten og effektiviteten til VNS Therapy®-systemet som tilleggsterapi versus en ingen stimuleringskontroll hos personer med behandlingsresistent depresjon (RECOVER)

3. november 2026 oppdatert av: LivaNova

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A prospective, multi-center, randomized, controlled, blinded trial of subjects implanted with VNS Therapy. Active treatment and no stimulation control are randomized, at least two weeks after implantation and observed for 12-months.

After completing the 12 month endpoint in the RCT portion of the study, all RECOVER subjects will transition into the prospective, open-label, longitudinal portion of the study. Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint.

After completion of enrollment in the RCT portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. These subjects will participate in the study for approximately 5 years.

The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development (CED) decision entitled "Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2).

Studietype

Intervensjonell

Registrering (Antatt)

6800

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Rekruttering
        • University of Alabama at Birmingham
        • Hovedetterforsker:
          • Matthew Macaluso, DO
        • Ta kontakt med:
      • Huntsville, Alabama, Forente stater, 35801
        • Rekruttering
        • UAB Huntsville Regional Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Clinton Martin, MD
    • California
      • Burlingame, California, Forente stater, 94010
        • Avsluttet
        • Access Multi Specialty Medical Clinic, Inc
      • Colton, California, Forente stater, 92324
        • Tilbaketrukket
        • CMB Clinical Trials
      • Costa Mesa, California, Forente stater, 92626
        • Rekruttering
        • ATP Clinical Research, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gustavo Alva, MD
      • La Jolla, California, Forente stater, 92037
        • Rekruttering
        • Salma Health
        • Hovedetterforsker:
          • Mohammed Ahmed, MD
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90033
        • Rekruttering
        • Keck Hospital of USC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ashraf Elmashat, MD
      • San Diego, California, Forente stater, 92103
        • Aktiv, ikke rekrutterende
        • University of California San Diego
      • San Rafael, California, Forente stater, 94901
        • Avsluttet
        • SF-CARE, Inc.
      • Santa Ana, California, Forente stater, 92705
        • Avsluttet
        • Syrentis Clinical Research
    • Florida
      • Boca Raton, Florida, Forente stater, 33431
        • Rekruttering
        • Mindful Behavioral Health
        • Hovedetterforsker:
          • Ivan Cichowicz, MD
        • Ta kontakt med:
      • Boca Raton, Florida, Forente stater, 33325
        • Avsluttet
        • Sunrise Research Institute
      • Brooksville, Florida, Forente stater, 34609
        • Avsluttet
        • Medycal Research, Inc
      • Hialeah, Florida, Forente stater, 33016
        • Rekruttering
        • Galiz Research LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jose Gamez, MD
      • Jacksonville, Florida, Forente stater, 32216
        • Rekruttering
        • Flourish Research - St. Augustine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Heather Luing
      • Largo, Florida, Forente stater, 33770
        • Avsluttet
        • Florida Behavioral Medicine
      • Lauderhill, Florida, Forente stater, 33319
        • Tilbaketrukket
        • Segal Trials Corporate
      • Miami, Florida, Forente stater, 33125
        • Tilbaketrukket
        • Central Miami Medical Institute, LLC
      • Miami, Florida, Forente stater, 33135
        • Tilbaketrukket
        • Research Center Of Florida, Inc
      • Miami, Florida, Forente stater, 33135
        • Avsluttet
        • Clintex Research Group, Inc.
      • Miami Springs, Florida, Forente stater, 33166
        • Tilbaketrukket
        • Ocean Blue Medical Research Center
      • Orlando, Florida, Forente stater, 32803
        • Rekruttering
        • Nova Psychiatry Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Medina, MD
      • Orlando, Florida, Forente stater, 32819
        • Tilbaketrukket
        • Millenia Psychiatry & Research, Inc
      • Orlando, Florida, Forente stater, 32806
        • Avsluttet
        • Florida Center for TMS
      • Orlando, Florida, Forente stater, 32803
        • Rekruttering
        • APG Research, LLC
        • Hovedetterforsker:
          • Morteza Nadjafi, MD
        • Ta kontakt med:
      • Pompano Beach, Florida, Forente stater, 33064
        • Avsluttet
        • Quantum Laboratories Inc.
      • Royal Palm Beach, Florida, Forente stater, 33411
        • Avsluttet
        • dTMS Center, LCC
      • Saint Augustine, Florida, Forente stater, 32086
        • Avsluttet
        • Florida Center for TMS
      • Tampa, Florida, Forente stater, 33613
        • Avsluttet
        • Stedman Clinical Trials
      • Tampa, Florida, Forente stater, 33634
        • Rekruttering
        • K2 Medical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kelley Wilson, MD
      • Tampa, Florida, Forente stater, 33612
        • Rekruttering
        • IPTB Clinical Research
        • Ta kontakt med:
          • Jamie Winderbaum Fernandez
          • Telefonnummer: 813-251-1800
        • Hovedetterforsker:
          • Jamie Winderbaum Fernandez
      • West Palm Beach, Florida, Forente stater, 33409
        • Avsluttet
        • Psychiatric Specialty Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Rekruttering
        • Emory University
        • Hovedetterforsker:
          • Patricio Riva Posse, MD
        • Ta kontakt med:
      • Augusta, Georgia, Forente stater, 30912
        • Rekruttering
        • Medical College of Georgia, Augusta University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Boadie Dunlop, MD
      • Decatur, Georgia, Forente stater, 30030
        • Avsluttet
        • PACT Atlanta LLC
      • Grayson, Georgia, Forente stater, 30017
        • Tilbaketrukket
        • IACT Health
      • Marietta, Georgia, Forente stater, 30060
        • Rekruttering
        • Psych Atlanta
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael Banov, MD
    • Idaho
      • Ammon, Idaho, Forente stater, 83406
        • Tilbaketrukket
        • Pearl Health Clinic
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rekruttering
        • Rush University Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Zajecka
      • Joliet, Illinois, Forente stater, 60435
        • Avsluttet
        • Joliet Center For Clinical Research
      • Naperville, Illinois, Forente stater, 60563
        • Rekruttering
        • AMR- Baber Research, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Riaz Baber, MD
      • Skokie, Illinois, Forente stater, 60076
        • Rekruttering
        • Psychiatric Medicine Associates, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Zajecka, MD
      • Springfield, Illinois, Forente stater, 62794
        • Rekruttering
        • Southern Illinois University School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kalyan Kandra, MD
      • Winfield, Illinois, Forente stater, 60910
        • Tilbaketrukket
        • Neuroscience Research Institute
    • Indiana
      • Indianapolis, Indiana, Forente stater, 56268
        • Avsluttet
        • Advanced Research Institute, Inc.
      • South Bend, Indiana, Forente stater, 46601
        • Aktiv, ikke rekrutterende
        • Beacon Medical Group Behavioral Health
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Rekruttering
        • University of Kansas Medical Center
        • Hovedetterforsker:
          • Tyler Kjorvestad, MD
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21204
        • Rekruttering
        • Sheppard Pratt Health System, Inc.
        • Hovedetterforsker:
          • Scott Aaronson, MD
        • Ta kontakt med:
      • Glen Burnie, Maryland, Forente stater, 21061
        • Tilbaketrukket
        • Clinical Insights
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Hovedetterforsker:
          • Cristina Cusin, MD
        • Ta kontakt med:
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48105
        • Rekruttering
        • Michigan Clinical Research Institute PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ravi Kirbat
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55416
        • Rekruttering
        • University of Minnesota
        • Hovedetterforsker:
          • Ziad Nahas, MD
        • Ta kontakt med:
          • Rachel Johnson
          • Telefonnummer: 952-525-4505
          • E-post: ipl@umn.edu
        • Ta kontakt med:
          • Kayla Thoen
          • Telefonnummer: 952-525-4505
          • E-post: ipl@umn.edu
    • Mississippi
      • Flowood, Mississippi, Forente stater, 39232
        • Rekruttering
        • Precise Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joseph Kwentus, MD
      • Jackson, Mississippi, Forente stater, 39216
        • Avsluttet
        • Andrew Bishop, MD
    • Missouri
      • Columbia, Missouri, Forente stater, 65212
        • Rekruttering
        • University of Missouri
        • Hovedetterforsker:
          • Muaid Ithman, MD
        • Ta kontakt med:
      • O'Fallon, Missouri, Forente stater, 633668
        • Rekruttering
        • Psychiatric Care and Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Canale, MD
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Donald Bohnenkamp, MD
      • St Louis, Missouri, Forente stater, 63128
        • Avsluttet
        • PsychCare Consultants Research
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68526
        • Rekruttering
        • Alivation Research, LLC
        • Hovedetterforsker:
          • Walter Duffy, MD
        • Ta kontakt med:
    • New Hampshire
      • Nashua, New Hampshire, Forente stater, 03060
        • Rekruttering
        • Healthy Perspective
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hisham Hafez, MD
    • New Jersey
      • Neptune City, New Jersey, Forente stater, 07753
        • Tilbaketrukket
        • Jersey Shore University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Tilbaketrukket
        • University of New Mexico - Psychiatric Center
    • New York
      • Amherst, New York, Forente stater, 14226
        • Rekruttering
        • Dent Neurological Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Horacio Capote, MD
      • Buffalo, New York, Forente stater, 14215
        • Tilbaketrukket
        • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
      • Lewiston, New York, Forente stater, 14092
        • Rekruttering
        • Trinity Medical
        • Hovedetterforsker:
          • Alfred Belen, MD
        • Ta kontakt med:
      • New York, New York, Forente stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
        • Hovedetterforsker:
          • James M Murrough, MD
        • Ta kontakt med:
      • New York, New York, Forente stater, 10019
        • Avsluttet
        • Hapworth Research Inc.
      • Staten Island, New York, Forente stater, 10312
        • Tilbaketrukket
        • Richmond Behavioral Associates
      • Stony Brook, New York, Forente stater, 11794
        • Avsluttet
        • Stony Brook University Hospital
      • Syracuse, New York, Forente stater, 13210
        • Avsluttet
        • State University Of New York Upstate Medical University
      • Woodbury, New York, Forente stater, 11797
        • Rekruttering
        • ManuMind Interventional Psychiatry
        • Hovedetterforsker:
          • Lucian Manu, MD
        • Ta kontakt med:
    • North Carolina
      • Cary, North Carolina, Forente stater, 27519
        • Avsluttet
        • The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health
      • Raleigh, North Carolina, Forente stater, 27606
        • Avsluttet
        • Mindpath Care Centers
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Tilbaketrukket
        • Wake Forest University Health Science
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Tilbaketrukket
        • University Hospitals Case Medical Center
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • The Ohio State University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kevin Reeves, MD
      • Fairlawn, Ohio, Forente stater, 44333
        • Rekruttering
        • Signature Research Associates, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Anand Chaturvedi
      • Garfield Heights, Ohio, Forente stater, 44125
        • Rekruttering
        • Charak Center for Health and Wellness
        • Hovedetterforsker:
          • Rakesh Ranjan, MD
        • Ta kontakt med:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73109-3834
        • Tilbaketrukket
        • NPC Research
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Avsluttet
        • Rivus Wellness & Research Institute
      • Tulsa, Oklahoma, Forente stater, 74135
        • Aktiv, ikke rekrutterende
        • University of Oklahoma School of Community Medicine
    • Pennsylvania
      • Moosic, Pennsylvania, Forente stater, 18507
        • Rekruttering
        • Scranton Medical Institutes
        • Hovedetterforsker:
          • Matthew Berger, MD
        • Ta kontakt med:
        • Ta kontakt med:
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Aktiv, ikke rekrutterende
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Rekruttering
        • Medical University of South Carolina
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mark George, MD
    • Tennessee
      • Brentwood, Tennessee, Forente stater, 37027
        • Rekruttering
        • Neuroscience and TMS Treatment Center
        • Hovedetterforsker:
          • Jonathan Becker, MD
        • Ta kontakt med:
    • Texas
      • Austin, Texas, Forente stater, 78712
      • Austin, Texas, Forente stater, 78759
        • Avsluttet
        • BioBehavioral Research of Austin
      • Dallas, Texas, Forente stater, 75390
        • Rekruttering
        • University of Texas Southwestern
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kala Bailey, MD
      • El Paso, Texas, Forente stater, 79905
        • Rekruttering
        • Texas Tech University Health Science Center
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77054
        • Rekruttering
        • The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders
        • Hovedetterforsker:
          • Joao De Quevedo, MD, PhD
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77401
        • Avsluttet
        • Houston Clinical Trials
      • Lewisville, Texas, Forente stater, 75057
        • Avsluttet
        • Northpointe Psychiatry
      • Missouri City, Texas, Forente stater, 77459
        • Avsluttet
        • Rise Clinical Research, LLC
    • Utah
      • Salt Lake City, Utah, Forente stater, 84108
        • Rekruttering
        • The University of Utah
        • Ta kontakt med:
          • Brian Mickey (PI), MD, PhD
          • Telefonnummer: 801-587-3297
        • Ta kontakt med:
    • Vermont
      • Woodstock, Vermont, Forente stater, 05091
        • Avsluttet
        • Neuropsychiatric Associates, Plc
    • Virginia
      • Roanoke, Virginia, Forente stater, 24014
        • Rekruttering
        • Carilion Clinic
        • Hovedetterforsker:
          • Anita Kablinger, MD
        • Ta kontakt med:
    • Washington
      • Mercer Island, Washington, Forente stater, 98040
        • Rekruttering
        • Center For Anxiety and Depression
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christina Demopulos, MD
      • Seattle, Washington, Forente stater, 98104
        • Rekruttering
        • Seattle Neuropsychiatric Treatment Center
        • Hovedetterforsker:
          • Rebecca Allen, MD
        • Ta kontakt med:
    • West Virginia
      • Huntington, West Virginia, Forente stater, 25701
        • Rekruttering
        • Marshall University Joan C. Edwards School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dakota May, MD
      • Morgantown, West Virginia, Forente stater, 26506
        • Tilbaketrukket
        • West Virginia Clinical and Translational Science Institute
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53719
        • Rekruttering
        • University of Wisconsin
        • Ta kontakt med:
        • Hovedetterforsker:
          • Steven Garlow

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.

The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.

The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.

Patients must maintain a stable medication regimen for at least four weeks before device implantation.

Exclusion Criteria:

Current or lifetime history of psychotic features in any MDE;

Current or lifetime history of schizophrenia or schizoaffective disorder;

Current or lifetime history of any other psychotic disorder;

Current or lifetime history of rapid cycling bipolar disorder;

Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;

Current suicidal intent; or

Treatment with another investigational device or investigational drugs.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Active

Group will have VNS activated 2 weeks post implant.
Enhet: Vagus Nerve Stimulation (VNS)

VNS is an implantable device that delivers stimulation to the vagal nerve.

Andre navn:
  • VNS
Sham-komparator: Control

Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Enhet: Vagus Nerve Stimulation (VNS)

VNS is an implantable device that delivers stimulation to the vagal nerve.

Andre navn:
  • VNS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
WHO Disability Assessment Schedule (WHODAS) Endringer i score over tid
Tidsramme: Baseline til 12 måneder
Baseline til 12 måneder
Health Outcome Scale (EQ-5D-L) Endringer i poengsum over tid
Tidsramme: Baseline til 12 måneder
Baseline til 12 måneder
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response
Tidsramme: 12 months post randomization

The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.
12 months post randomization
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response
Tidsramme: Baseline up to 12 Months

Time from randomization to the first observed MADRS response.
Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission
Tidsramme: Baseline up to 12 Months

Time from randomization to the first observed MADRS remission.
Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response
Tidsramme: Baseline up to 12 Months

Duration of MADRS response, defined as the number of consecutive months from first observed MADRS response to the first assessment of MADRS response relapse.
Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission
Tidsramme: Baseline up to 12 Months

The rate of remission is defined as total number of months in remission divided by total months of expected study participation. Subjects discontinuing the study before the endpoint assessment will be considered as non-in-remission for each successive month after discontinuance
Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response
Tidsramme: Baseline up to 12 Months

Maximum duration of MADRS response, defined as the maximum number of consecutive months in response (only for subjects experiencing MADRS response).
Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission
Tidsramme: Baseline up to 12 Months

Duration of MADRS remission, defined as the number of consecutive months from first observed MADRS remission to the first assessment of MADRS remission relapse (defined score > 20).
Baseline up to 12 Months
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission
Tidsramme: Baseline up to 12 Months

Maximum duration of MADRS remission, defined as the maximum number of consecutive months in remission (only for subjects experiencing MADRS remission).
Baseline up to 12 Months
Assess all Adverse Events
Tidsramme: Implant to 12 Months

All adverse events, with a focus on device or procedure-related serious adverse events.
Implant to 12 Months
Clinical Global Impressions Scale - Improvement (CGI-I) Response
Tidsramme: 12 months post randomization

A CGI-I score ≤ 2 at 12 months from randomization. Subjects discontinuing the study before the 12 months assessment will be considered as not in response for each successive month after discontinuance.
12 months post randomization
Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality
Tidsramme: Implant to 12 Months

Suicide attempts as measured by items #10 & #12 in S-STS scale
Implant to 12 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

LivaNova

Etterforskere

  • Hovedetterforsker: Charles Conway, MD, Washington University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. september 2019

Primær fullføring (Antatt)

28. februar 2028

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

21. mars 2019

Først innsendt som oppfylte QC-kriteriene

21. mars 2019

Først lagt ut (Faktiske)

25. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LND-300

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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