Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

25 de julio de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

134

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Biológico: Botulinum toxin type A
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Otros nombres:
  • AbobotulinumtoxinA (Dysport®)
Comparador de placebos: Placebo
Placebo, up to 2mL
Droga: Placebo
Up to 2mL

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in TWSTRS Total Score at Week 2.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ipsen

Investigadores

  • Director de estudio: Medical Director, Neurology, M.D., Ipsen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2013

Finalización primaria (Actual)

1 de octubre de 2014

Finalización del estudio (Actual)

1 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

17 de diciembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

17 de diciembre de 2012

Publicado por primera vez (Estimar)

20 de diciembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

25 de julio de 2019

Última verificación

1 de julio de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A-TL-52120-169

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Distonía cervical

Ensayos clínicos sobre Botulinum toxin type A

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Argentina

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir