Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Patrocinadores

Patrocinador principal: Novartis

Fuente Novartis
Resumen breve

This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

Estado general Completed
Fecha de inicio September 2009
Fecha de finalización primaria December 2010
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score 12 weeks
Resultado secundario
Medida Periodo de tiempo
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score 12 weeks
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change 12 weeks
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) 12 weeks
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD 12 weeks
Inscripción 260
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: AFQ056

Etiqueta de grupo de brazo: AFQ056-10mg

Tipo de intervención: Drug

Nombre de intervención: AFQ056

Etiqueta de grupo de brazo: AFQ056-25mg

Tipo de intervención: Drug

Nombre de intervención: AFQ056

Etiqueta de grupo de brazo: AFQ056-50mg

Tipo de intervención: Drug

Nombre de intervención: AFQ056

Etiqueta de grupo de brazo: AFQ056-75mg

Tipo de intervención: Drug

Nombre de intervención: AFQ056

Etiqueta de grupo de brazo: AFQ056-100mg

Tipo de intervención: Drug

Nombre de intervención: Placebo

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

Inclusion Criteria:

- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months

Exclusion Criteria:

- Surgical treatment for PD

- Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)

- Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Género: All

Edad mínima: 30 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Ubicación
Instalaciones:
Novartis Investigative Site | East Gosford, 2250, Australia
Novartis Investigative Site | Heidelberg, Australia
Novartis Investigative Site | Melbourne, 3050, Australia
Novartis Investigative Site | Parkville, 3181, Australia
Novartis Investigational Site | Westmead, NSW 2145, Australia
Clinique Neuro-Outaouais | Gatineau, J9J 0A5, Canada
Recherches Pembina, Inc | Greenfield Park, J4V 2J2, Canada
Novartis Investigative Site | Montreal, H2L 4M1, Canada
Parkinson's and Neurodegenerative Disorders Clinic | Ottawa, K1G 4G3, Canada
Quebec Memory & Motor Skills Disorders Clinic | Quebec, G1R 3X5, Canada
Toronto Western Hospital, UHN | Toronto, M5T 2S8, Canada
Novartis Investigative Site | Vancouver, V6T 2B5, Canada
Novartis Investigative Site | Kuopio, Finland
Novartis Investigative Site | Lahti, 15110, Finland
Novartis Investigative Site | Oulu, 90220, Finland
Novartis Investigative Site | Tampere, 33520, Finland
Novartis Investigative Site | Turku, 20520, Finland
Novartis Investigative Site | Clermont Ferrand Cedex, 63003, France
Novartis Investigative Site | Lille Cedex, 59037, France
Novartis Investigative Site | Pessac, 33604, France
Novartis Investigative Site | St. Herblain, 44800, France
Novartis Investigative Site | Toulouse, 31059, France
Novartis Investigative Site | Beelitz-Heilstaetten, 14547, Germany
Novartis Investigative Site | Berlin, 13088, Germany
Novartis Investigative Site | Bochum, Germany
Novartis Investigative Site | Dresden, 01307, Germany
Novartis Investigative Site | Kassel, 34128, Germany
Novartis Investigative Site | Marburg, 35039, Germany
Novartis Investigative Site | Muenchen, 80804, Germany
Novartis Investigative Site | Stadtroda, 07646, Germany
Novartis Investigative Site | Tuebingen, 72076, Germany
Novartis Investigative Site | Lido di Camaiore, 55041, Italy
Novartis Investigative Site | Napoli, 80131, Italy
Novartis Investigative Site | Roma, 00163, Italy
Novartis Investigative Site | Roma, 00185, Italy
Novartis Investigative Site | Fukuoka, 814-0180, Japan
Novartis Investigative Site | Tochigi, 329-0498, Japan
Novartis Investigative Site | Tokyo, 113-8431, Japan
Novartis Investigative Site | Tokyo, 136-0075, Japan
Novartis Investigative SIte | Tokyo, 187-8551, Japan
Novartis Investigative Site | Toon, 791-0295, Japan
Novartis Investigative Site | Wakayama, 641-8510, Japan
Novartis Investigative Site | Barcelona, 08036, Spain
Novartis Investigative Site | Barcelona, 08190, Spain
Novartis Investigative Site | Barcelona, Spain
Novartis Investigative Site | Madrid, 28034, Spain
Novartis Investigative Site | San Sebastian, Spain
Ubicacion Paises

Australia

Canada

Finland

France

Germany

Italy

Japan

Spain

Fecha de verificación

February 2017

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 6
Grupo de brazo

Etiqueta: AFQ056-10mg

Tipo: Experimental

Etiqueta: AFQ056-25mg

Tipo: Experimental

Etiqueta: AFQ056-50mg

Tipo: Experimental

Etiqueta: AFQ056-75mg

Tipo: Experimental

Etiqueta: AFQ056-100mg

Tipo: Experimental

Etiqueta: Placebo

Tipo: Placebo Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov