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Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

25. juli 2019 opdateret af: Ipsen

A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Movement Disorders Center of Arizona, LLC
      • Tucson, Arizona, Forenede Stater, 85724
        • University of Arizona
    • California
      • Berkeley, California, Forenede Stater, 94705
        • East Bay Physician's Group
      • Fountain Valley, California, Forenede Stater, 92708
        • Parkinson's and Movement Disorder Institute
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Healthcare, Department of Neurology
      • Los Angeles, California, Forenede Stater, 90033
        • USC Keck School of Medicine
      • Sacramento, California, Forenede Stater, 95817
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado at Denver Health Sciences
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Advanced Neurosciences Research
    • Connecticut
      • Fairfield, Connecticut, Forenede Stater, 06824
        • Associated Neurologists of Southern Connecticut
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown University Hospital
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Parkinson's & Movement Disorders Center of Boca Raton
      • Gainesville, Florida, Forenede Stater, 32607
        • University of Florida Center for Movement Disorders and Neurorestoration
      • Pensacola, Florida, Forenede Stater, 32514
        • Emerald Coast Center for Neurological Disorders
      • Port Charlotte, Florida, Forenede Stater, 33980
        • PD Treatment Center of SW FL
      • Tampa, Florida, Forenede Stater, 33606
        • University of South Florida
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Premiere Research Institute at Palm Beach Neurology
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Guilford Neurologic Associates
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30329
        • Emory University
      • Atlanta, Georgia, Forenede Stater, 30342
        • NeuroTrials Research Inc.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66211
        • Kansas City Bone & Joint Clinic
      • Overland Park, Kansas, Forenede Stater, 66210
        • International Clinical Research Institute
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
    • Minnesota
      • Eagan, Minnesota, Forenede Stater, 55122
        • Rehabilitation Consultants PA
    • New Jersey
      • Stratford, New Jersey, Forenede Stater, 08084
        • University of Medicine and Dentistry of New Jersey
      • Summit, New Jersey, Forenede Stater, 07901
        • Atlantic Neuroscience Institute
    • New York
      • Kingston, New York, Forenede Stater, 12401
        • Kingston Neurological Associates
      • New York, New York, Forenede Stater, 10029
        • The Ichan School of Medicine at Mount Sinai
      • New York, New York, Forenede Stater, 10016
        • Fazzini Parkinson's Disease & Dystonia Center
      • Plainview, New York, Forenede Stater, 11803
        • Island Neurological Associates
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27405
        • Guilford Neurologic Associates; Cone Health Medical Group
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest School of Medicine
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati Physicians Company, LLC
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • OHSU Center for Health and Healing
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Hershey Neurology
    • South Carolina
      • Port Royal, South Carolina, Forenede Stater, 29935
        • Coastal Neurology
    • Texas
      • Bedford, Texas, Forenede Stater, 76201
        • North Texas Movement Disorders Institute
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas Health Science Center at Houston
    • Washington
      • Tacoma, Washington, Forenede Stater, 98409
        • Puget Sound Neurology

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
  • TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

  • In apparent remission from Cervical Dystonia
  • Diagnosis of pure retrocollis or pure anterocollis
  • For non-naïve subjects, previous poor response to either of the last two Botox treatments
  • Known requirement of <100U or >200U of Botox injected into the neck muscles

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Biologisk: Botulinum toxin type A
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Andre navne:
  • AbobotulinumtoxinA (Dysport®)
Placebo komparator: Placebo
Placebo, up to 2mL
Medicin: Placebo
Up to 2mL

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Tidsramme: 4 weeks post-treatment
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
4 weeks post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in TWSTRS Total Score at Week 2.
Tidsramme: 2 weeks post-treatment
The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
2 weeks post-treatment
Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.
Tidsramme: 2 weeks post-treatment
The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
2 weeks post-treatment
TWSTRS Responders at Week 2.
Tidsramme: 2 weeks post-treatment
Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.
2 weeks post-treatment
Change From Baseline in CGIC in CD at Week 4.
Tidsramme: 4 weeks post-treatment
The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
4 weeks post-treatment
TWSTRS Responders at Week 4.
Tidsramme: 4 weeks post-treatment
Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.
4 weeks post-treatment
Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.
Tidsramme: 4 weeks post-treatment
The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.
4 weeks post-treatment
Change From Baseline in CDIP-58 Total Score at Week 2.
Tidsramme: 2 weeks post-treatment
The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.
2 weeks post-treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Ipsen

Efterforskere

  • Studieleder: Medical Director, Neurology, M.D., 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

1. januar 2013

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

17. december 2012

Først indsendt, der opfyldte QC-kriterier

17. december 2012

Først opslået (Skøn)

20. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A-TL-52120-169

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 .

Kliniske forsøg med Cervikal dystoni

Kliniske forsøg med Botulinum toxin type A

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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