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

25 juli 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

134

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Biologisch: Botulinum toxin type A
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Andere namen:
  • AbobotulinumtoxineA (Dysport®)
Placebo-vergelijker: Placebo
Placebo, up to 2mL
Geneesmiddel: Placebo
Up to 2mL

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in TWSTRS Total Score at Week 2.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ipsen

Onderzoekers

  • Studie directeur: Medical Director, Neurology, M.D., Ipsen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2013

Primaire voltooiing (Werkelijk)

1 oktober 2014

Studie voltooiing (Werkelijk)

1 januari 2015

Studieregistratiedata

Eerst ingediend

17 december 2012

Eerst ingediend dat voldeed aan de QC-criteria

17 december 2012

Eerst geplaatst (Schatting)

20 december 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2019

Laatste update ingediend die voldeed aan QC-criteria

25 juli 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A-TL-52120-169

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op Botulinum toxin type A

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