Clinical trial NCT00986414: Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Dyskinesias
Keywords: Parkinson Disease
L-dopa
Levodopa
dyskinesia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 260
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
timeFrame: 12 weeks
Secondary outcomes:
measure: Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
Other outcomes:
Locations:
city: East Gosford
country: Australia
facility: Novartis Investigative Site
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
city: Melbourne
country: Australia
facility: Novartis Investigative Site
city: Parkville
country: Australia
facility: Novartis Investigative Site
city: Westmead
country: Australia
facility: Novartis Investigational Site
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
city: Greenfield Park
country: Canada
facility: Recherches Pembina, Inc
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: Ottawa
country: Canada
facility: Parkinson's and Neurodegenerative Disorders Clinic
city: Quebec
country: Canada
facility: Quebec Memory & Motor Skills Disorders Clinic
city: Toronto
country: Canada
facility: Toronto Western Hospital, UHN
city: Vancouver
country: Canada
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Lahti
country: Finland
facility: Novartis Investigative Site
city: Oulu
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Clermont Ferrand Cedex
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: St. Herblain
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Beelitz-Heilstaetten
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Stadtroda
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Tochigi
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative SIte
city: Toon
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.