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En undersøgelse for at sammenligne sikkerheden og effektiviteten af ​​Dysport® og Botox® hos voksne med spasticitet i øvre lemmer. (DIRECTION)

12. juni 2026 opdateret af: Ipsen

En multicenter, interventionel, post-marketing, randomiseret, dobbeltblind, crossover-undersøgelse for at evaluere den kliniske sikkerhed og effektivitet af AbobotulinumtoxinA (Dysport®) i sammenligning med OnabotulinumtoxinA (Botox®) ved behandling af voksne med spasticitet i øvre lemmer

Denne undersøgelse har til formål at demonstrere non-inferioriteten af ​​AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) som det primære sikkerhedsendepunkt, og aboBoNT-A's overlegenhed over onaBoNT-A med hensyn til varigheden af ​​respons som nøglen sekundært effektmål, når det anvendes i optimale doser i henhold til godkendte ordinationsoplysninger for hvert produkt.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

464

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Canada
      • Moncton, Canada, E1C 6Z8
        • Moncton Hospital
      • Montreal, Canada, H3A 2B4
        • Genge Partners
      • Victoria, Canada, V9A 3P2
        • Victoria General Hospital
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Lawson Health Research Institute
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 25233
        • University of Alabama
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Movement Disorders Center of Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • HonorHealth Scottsdale Osborn Medical Center
      • Tucson, Arizona, Forenede Stater, 85724
        • The University of Arizona
    • California
      • Downey, California, Forenede Stater, 90242
        • Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
      • Fountain Valley, California, Forenede Stater, 92708
        • Parkinson's & Movement Disorders Institute
      • Fresno, California, Forenede Stater, 93710
        • Neuro-Pain Medical Center
      • Loma Linda, California, Forenede Stater, 92350
        • Loma Linda University Health Care
      • Long Beach, California, Forenede Stater, 90808
        • Southland Neurologic Institute
      • Los Angeles, California, Forenede Stater, 90095
        • University of California Los Angeles
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Hasbani And Hasbani Medical Group
      • Stamford, Connecticut, Forenede Stater, 06905
        • Ki Health Partners LLC D/B/A New England Institute for Clinical Research
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33428
        • First Choice Neurology
      • Tampa, Florida, Forenede Stater, 33612
        • James A Haley Veterans Hospital
      • Tampa, Florida, Forenede Stater, 33612
        • University of South Florida Health-Morsani Center for Advanced Healthcare
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University of School of Medicine
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Pacific Neuroscience
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611-3167
        • Shirley Ryan Ability Lab
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Fort Wayne Neurological Center
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66211-1358
        • Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • LSU Healthcare network
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Dearborn, Michigan, Forenede Stater, 48124
        • William Beaumont Hospital
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Medical Rehabilitation Group, PC
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Mary Free Bed Rehabilitation Hospital
      • Grosse Pointe, Michigan, Forenede Stater, 48230
        • Beaumont Hospital, Grosse Pointe
      • Grosse Pointe, Michigan, Forenede Stater, 48334
        • Michigan Center of Medical Research
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203-3248
        • Rusk Rehabilitation Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Wr-Crcn, Llc
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08003
        • Cooper University Health Care
    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University
      • New York, New York, Forenede Stater, 10065
        • Weill Cornell Medicine Clinical and Translational Science Center
      • Port Jefferson, New York, Forenede Stater, 11725
        • North Suffolk Neurology
      • Rochester, New York, Forenede Stater, 55905
        • Mayo Clinic
      • Schenectady, New York, Forenede Stater, 12308
        • Sunnyview Rehabilitation Hospital
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University Medical Center
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic - Neurological Institute
    • Pennsylvania
      • Elkins Park, Pennsylvania, Forenede Stater, 20010
        • MossRehab - Einstein Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Health Physical Medicine and Rehabilitation - Neurology
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center (UPMC)
      • Wayne, Pennsylvania, Forenede Stater, 19087
        • Aether Medicine
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Siskin Hospital for Rehabilitation - Neurology
      • Nashville, Tennessee, Forenede Stater, 37232
        • The Vanderbilt Clinic
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas Southwestern
      • Houston, Texas, Forenede Stater, 77030
        • TIRR Memorial Hermann Research Center
      • San Antonio, Texas, Forenede Stater, 78229
        • UT Health San Antonio
      • Sherman, Texas, Forenede Stater, 75093
        • Texas Institute for Neurological Disorders
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah School of Medicine
    • Virginia
      • Roanoke, Virginia, Forenede Stater, 24016
        • Carilion Clinic Institute of Orthopaedics and Neurosciences
    • Washington
      • Columbia, Washington, Forenede Stater, 20010
        • MedStar National Rehabilitation Network
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Neuroscience Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin - Froedtert Hospital
  • Frankrig
      • Angers, Frankrig, 49100
        • Centre Les Capucins
      • Bordeaux, Frankrig, 33000
        • Hopital Pellegrin CHU Bordeaux
      • Marseille, Frankrig, 13384
        • Hôpital d'Instruction des Armées Laveran
      • Nantes, Frankrig, 44000
        • Hôpital Saint-Jacques (CHU Nantes)
      • Nice, Frankrig, 06202
        • Hopital Archet (CHU de Nice)
      • Paris, Frankrig, 75010
        • Hopital Fernand Widal
      • Ploemeur, Frankrig
        • Centre Mutualiste de Rééducation et de Réadaptation Fonction
      • Poitiers, Frankrig, 86000
        • Hôpital Jean Bernard (CHU Poitiers)
      • Rennes, Frankrig, 35043
        • Pole Saint Helier
      • Rennes, Frankrig, 35033
        • Hôpital Pontchaillou (CHU Rennes)
      • Roscoff, Frankrig, 29680
        • Centre de Perharidy
      • Saint-Amand-Montrond, Frankrig, 18200
        • Centre Hospitalier de Saint Amand Montrond
      • Saint-Amand-les-Eaux, Frankrig, 59230
        • Centre Hospitalier de Saint-Amand-les-Eaux
      • Saint-Genis-Laval, Frankrig, 69230
        • Hopital Henry Gabrielle (HCL)
      • Strasbourg, Frankrig, 67091
        • Hopitaux Universitaires de Strasbourg
      • Toulouse, Frankrig, 31059
        • Hôpital de Rangueil
      • Échirolles, Frankrig, 38434
        • Hopital Sud
  • Puerto Rico
    • Puerto Rico
      • Santurce, Puerto Rico, Puerto Rico, 00912
        • University of Puerto Rico

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltageren skal være 18 til 75 år inklusive, på tidspunktet for underskrivelsen af ​​det informerede samtykke
  • 2a. [US/Frankrig] Deltagere med stabil øvre lemmerspasticitet (ULS) i mindst 3 måneder, hvor behandling af kun én øvre lemmer er nødvendig i undersøgelsens varighed;
  • 2b. [Canada] Deltagere med stabil post-slagtilfælde ULS i mindst 3 måneder, hvor behandling af kun en øvre lemmer er nødvendig i undersøgelsens varighed
  • Deltagere, der enten er naive over for botulinumtoksin type A (BoNT-A) for ULS eller som tidligere er blevet behandlet med BoNT-A for ULS;
  • Deltagere med MAS-score på mindst 2 ved albue-, håndleds- og fingerbøjere;
  • Deltagere med DAS-score på mindst 2 på hovedmålet for behandling (PTT) (et af fire funktionelle domæner: påklædning, hygiejne, lemmerposition og smerte);
  • Deltagere, der kræver BoNT-A-injektion i alle følgende muskler: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis og biceps brachii;
  • Deltagere, for hvem injektion af en samlet dosis på 900 enheder aboBoNT-A eller 360 enheder onaBoNT-A af investigator anses for at være klinisk passende;
  • Deltagere, der har været stabile i mindst 3 måneder før studiestart med hensyn til oral antispasticitet, antikoagulerende og/eller antikolinerg medicin, hvis de er behandlet, og i mindst 1 måned før studiestart med hensyn til erhvervs- og/eller fysioterapibehandling, hvis behandlet og anses af investigator for at forblive stabile i hele undersøgelsens varighed;

Ekskluderingskriterier:

  • Større begrænsninger i det passive bevægelsesområde i den paretiske overekstremitet;
  • Større neurologisk svækkelse (bortset fra lemmerparese), som kan påvirke funktionel ydeevne negativt;
  • Deltagere, der klinisk kræver injektion i andre muskler i overekstremiteterne end de fem muskler i den ene arm, der er anført i afsnit 5.1, eller som kræver injektion i begge arme eller en hvilken som helst underekstremitet inden for undersøgelsens tidsramme;
  • Overfølsomhed over for ethvert BoNT-produkt eller hjælpestoffer;
  • Overfølsomhed over for komælksprotein (kasein);
  • Infektion på det eller de foreslåede injektionssteder;
  • Kendte perifere motorneuropatiske sygdomme, amyotrofisk lateral sklerose eller neuromuskulære junction lidelser (f.eks. myasthenia gravis eller Lambert-Eatons syndrom);
  • Enhver medicinsk tilstand (herunder dysfagi eller åndedrætsbesvær/kompromitteret åndedrætsfunktion), der efter investigatorens mening kan bringe deltagerens sikkerhed i fare;
  • Kvinder, der er gravide eller ammende
  • Deltagere behandlet med BoNT af enhver type for enhver indikation (f.eks. blæreinjektion, hovedpine eller kosmetik) inden for de foregående 12 uger eller planlagt/sandsynligvis behandlet i løbet af undersøgelsen;
  • Tidligere manglende respons på BoNT-behandling;
  • Tidligere operation eller administration af alkohol eller phenol i undersøgelseslemmet 6 måneder eller tidligere fra studietilmeldingen eller planlagt/sandsynligvis behandlet i løbet af undersøgelsen;
  • Deltagere behandlet med intrathecal baclofen (undtagen hvis behandlingen har nået en stabil dosis i >4 uger og sandsynligvis vil forblive stabil gennem hele undersøgelsen), aminoglykosider eller andre midler, der forstyrrer neuromuskulær transmission (f.eks. curare-lignende midler) inden for de 4 uger før studietilmelding eller planlagt/sandsynligvis behandlet i løbet af studiet
  • Deltagere, der modtog en COVID-19-vaccineinjektion inden for 7 dage før den første planlagte undersøgelsesinterventionsinjektion, eller planlagde/sandsynligvis at blive vaccineret inden for 7 dage efter den første planlagte undersøgelsesinterventionsinjektion
  • BoNT-naive deltagere med en historie med neurogen ansigtslidelse (ansigtslammelse, polyradiculoneuropati) (kun for Frankrig).

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: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Sekvens 1
Deltagerne vil modtage en cyklus af aboBoNT-A efterfulgt af en cyklus af onaBoNT-A i de valgte overaktive muskler i overekstremiteterne
Biologisk: AboBoNT-A
AbobotulinumtoxinA til injektion: 500 Enheder hætteglas. Dosis: 900 enheder (3,6 ml)
Andre navne:
  • Dysport®
Biologisk: OnaBoNT-A
OnabotulinumtoxinA til injektion: 200 Enheder hætteglas. Dosis: 360 enheder (3,6 ml)
Andre navne:
  • Botox®
Andet: Sekvens 2
Deltagerne vil modtage en cyklus af onaBoNT-A efterfulgt af en cyklus af aboBoNT-A i de valgte overaktive muskler i overekstremiteterne
Biologisk: AboBoNT-A
AbobotulinumtoxinA til injektion: 500 Enheder hætteglas. Dosis: 900 enheder (3,6 ml)
Andre navne:
  • Dysport®
Biologisk: OnaBoNT-A
OnabotulinumtoxinA til injektion: 200 Enheder hætteglas. Dosis: 360 enheder (3,6 ml)
Andre navne:
  • Botox®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) From Injection to 12 Weeks
Tidsramme: From Baseline (Injection: Day 1) up to 12 weeks
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A TEAE was defined for each treatment cycle as any AE that occurred during the cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but the intensity increased during the cycle. Percentage of participants with TEAEs that occurred during each cycle from injection to 12 weeks after injection (until 84 days after injection or until the day prior to next injection day or until end of study/early withdrawal day whichever occurred first) is presented. Percentages are rounded off to the tenth decimal place.
From Baseline (Injection: Day 1) up to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Drug Reactions (ADRs), Treatment-Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) From Injection to 12 Weeks
Tidsramme: From Baseline (Injection: Day 1) up to 12 weeks
AE: any untoward medical occurrence in a clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product, or any other medically important event. TEAE for each treatment cycle: any AE that occurred during cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but intensity increased during cycle. ADR: any TEAE that was assessed by Investigator as related to study treatment. AESI: TEAE that suggested a possible remote spread of toxin or events suggestive of hypersensitivity like reactions.
From Baseline (Injection: Day 1) up to 12 weeks
Adjusted Least Square Mean of Duration of Response Based on Retreatment Criteria
Tidsramme: Baseline (Day 1) up to Week 10 (earliest) if retreatment criteria were met, or up to Week 24 (latest) if retreatment criteria were not met
The duration of response was defined for Cycle 1 as time between Cycle 1 injection and the first Cycle 1 visit when retreatment criteria were met (from Week 10 visit), or time between Cycle 1 injection and study withdrawal if the participant discontinued from the study before Cycle 2 injection without meeting retreatment criteria; for Cycle 2 as time between Cycle 2 injection and the first Cycle 2 visit when retreatment criteria were met (from Week 10 visit), or time between Cycle 2 injection and end of study if the participant completed the study or discontinued from the study after Cycle 2 injection without meeting retreatment criteria. It was calculated as the date of retreatment criteria met or withdrawal date (or last visit date for lost to follow-up participants) or completion date - date of injection + 1.
Baseline (Day 1) up to Week 10 (earliest) if retreatment criteria were met, or up to Week 24 (latest) if retreatment criteria were not met
Adjusted Least Square Mean of Muscle Tone Assessed by the Modified Ashworth Scale (MAS) for Finger, Wrist and Elbow Flexors Based on Primary Target Muscle Group (PTMG) at Week 12
Tidsramme: Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks)
Muscle tone for finger, wrist, elbow flexors assessed with MAS tool using scale: 0= no increase in muscle tone, 1= slight increase in muscle tone, manifested by a catch and release or by minimal resistance at end of range of motion (ROM) when affected part(s) was moved in flexion or extension, 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout remainder of ROM, 2= more marked increase in muscle tone through most of ROM, but affected part(s) easily moved, 3= considerable increase in muscle tone, passive movement difficult, 4= affected part(s) rigid in flexion or extension. PTMG included finger, wrist or elbow flexors which were selected by Investigators at screening as muscle group with highest MAS score. MAS total score was calculated as the sum of scores for all 3 joints (finger, wrist, elbow), ranged from: 0 (best) to 12 (worst); higher scores indicated worse outcomes.
Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks)
Adjusted Least Square Mean of Perceived Function and Pain Assessed by the Disability Assessment Scale (DAS) Based on Principal Target of Treatment (PTT) at Week 12
Tidsramme: Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks)
The DAS was used to determine the extent of functional impairment in 4 domains: hygiene, dressing, limb position and pain. Impairment was assessed on a 4-point scale: 0= no disability, 1= mild disability (noticeable but did not interfere significantly with normal activities), 2= moderate disability (normal activities required increased effort and/or assistance) and 3= severe disability (normal activities limited). The 4 domain ratings were added to obtain DAS total score which ranged between 0 (best) and 12 (worst); higher scores indicated severe disability. The PTT was defined at screening as 1 of the 4 domains, with an associated DAS score for assessment.
Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks)
Adjusted Least Square Mean of Physician Global Assessment (PGA) of Treatment Response at Week 12
Tidsramme: Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks)
The PGA of treatment response was assessed by asking the Investigator the following question: 'how would you rate the response to treatment in the participant's upper limb since the last injection?' and answered on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). Higher scores indicate greater better outcomes. 'Any improvement' in PGA was defined by a score including: +1, +2, +3 and +4.
Week 12 (Cycles 1 and 2; each cycle was 12 to 24 weeks)
Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life (QoL) Assessed by the 12-Item Short Form (SF-12) Health Survey Perceived Health Score: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) Scores
Tidsramme: Baseline (Day 1) and Weeks 4, 12, and 24 (end of cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks)
SF-12 consisted of 12 questions & asked respondent to answer questions as they pertained to way he/she felt or acted during past week. SF-12 covered 8 domains of health:physical functioning(PF),role physical(RP),bodily pain(BP),general health(GH),vitality(VT),social functioning(SF),role emotional(RE) & mental health(MH). Score range for each of 8 domains:0(maximum disability) to 100(no disability);higher scores:good QoL. Responses on SF-12 were used to obtain 2 summary scores:PCS-12 contributed by PF,RP,BP, and GH and MCS-12 contributed by MH,RE,SF and VT. Summations of item scores of same domains gave sub-scale scores,which were transformed to obtain summary scores of PCS-12 & MCS-12. Both PCS-12 & MCS-12 scores ranged from 0(worst) to 100(best);higher scores:better QoL.Baseline:last non-missing measurement prior to first study treatment administration.Change from baseline in QoL assessed by SF-12 health survey perceived health score based on PCS-12 and MCS-12 scores is presented.
Baseline (Day 1) and Weeks 4, 12, and 24 (end of cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks)
Change From Baseline to Weeks 4, 12 and 24 (End of Cycle) in Quality of Life Assessed by the Spasticity-Related Quality of Life Tool (SQoL-6D)
Tidsramme: Baseline (Day 1) and Weeks 4, 12, and 24 (end of Cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks)
The SQoL-6D questionnaire was a brief questionnaire in 6 domains: pain/discomfort, involuntary movements or spasms, restricted range of movement, caring for the affected limb, using the affected limb and mobility/balance which was designed to assess QoL in relation to spasticity that affected the upper limb, which included the arm, shoulder or hand. Each dimension was assessed by asking participants about symptoms within the last 7 days, using a 5-level scale ranging from 0 (best) to 4 (worst); higher scores indicated worse condition. The mean of the 6-dimension scores was calculated to obtain the total score which ranged from 0 (worse) to 100 (best); higher score indicated better QoL. Baseline was defined as the last non-missing measurement prior to first study treatment administration. Change from Baseline in QoL assessed by SQoL-6D is presented.
Baseline (Day 1) and Weeks 4, 12, and 24 (end of Cycle) (Cycles 1 and 2; each cycle was 12 to 24 weeks)

Samarbejdspartnere og efterforskere

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

Sponsor

Ipsen

Efterforskere

  • Studieleder: Ipsen Medical Director, Ipsen

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

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. juni 2021

Primær færdiggørelse (Faktiske)

26. august 2025

Studieafslutning (Faktiske)

26. august 2025

Datoer for studieregistrering

Først indsendt

9. juni 2021

Først indsendt, der opfyldte QC-kriterier

22. juni 2021

Først opslået (Faktiske)

23. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLIN-52120-452
  • 2021-000161-32 (EudraCT nummer)
  • 2023-509196-16-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på patientniveau og relaterede undersøgelsesdokumenter, herunder den kliniske undersøgelsesrapport, undersøgelsesprotokol med eventuelle ændringer, kommenteret caserapportformular, statistisk analyseplan og datasætspecifikationer. Data på patientniveau vil blive anonymiseret, og undersøgelsesdokumenter vil blive redigeret for at beskytte forsøgsdeltagernes privatliv.

Eventuelle anmodninger skal sendes til www.vivli.org til vurdering af et uafhængigt videnskabeligt bedømmelsesudvalg.

IPD-delingstidsramme

Hvor det er relevant, er data fra kvalificerede undersøgelser tilgængelige 6 måneder efter, at den undersøgte medicin og indikation er blevet godkendt i USA og EU, eller efter at det primære manuskript, der beskriver resultaterne, er blevet accepteret til offentliggørelse, alt efter hvad der er senere.

IPD-delingsadgangskriterier

Yderligere detaljer om Ipsens delingskriterier, kvalificerede undersøgelser og proces for deling er tilgængelige her (https://vivli.org/members/ourmembers/).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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