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

25 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

134

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Biologico: Botulinum toxin type A
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Altri nomi:
  • AbobotulinumtoxinA (Dysport®)
Comparatore placebo: Placebo
Placebo, up to 2mL
Droga: Placebo
Up to 2mL

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in TWSTRS Total Score at Week 2.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ipsen

Investigatori

  • Direttore dello studio: Medical Director, Neurology, M.D., Ipsen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2013

Completamento primario (Effettivo)

1 ottobre 2014

Completamento dello studio (Effettivo)

1 gennaio 2015

Date di iscrizione allo studio

Primo inviato

17 dicembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

17 dicembre 2012

Primo Inserito (Stima)

20 dicembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A-TL-52120-169

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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