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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986414
• Other study ID #: CAFQ056A2208
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2009
• Last updated: February 20, 2017
• Start date: September 2009

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• AFQ056

• AFQ056

• AFQ056

• AFQ056

• AFQ056

• Placebo

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	East Gosford
Australia	Novartis Investigative Site	Heidelberg
Australia	Novartis Investigative Site	Melbourne
Australia	Novartis Investigative Site	Parkville
Australia	Novartis Investigational Site	Westmead
Canada	Clinique Neuro-Outaouais	Gatineau
Canada	Recherches Pembina, Inc	Greenfield Park
Canada	Novartis Investigative Site	Montreal
Canada	Parkinson's and Neurodegenerative Disorders Clinic	Ottawa
Canada	Quebec Memory & Motor Skills Disorders Clinic	Quebec
Canada	Toronto Western Hospital, UHN	Toronto
Canada	Novartis Investigative Site	Vancouver
Finland	Novartis Investigative Site	Kuopio
Finland	Novartis Investigative Site	Lahti
Finland	Novartis Investigative Site	Oulu
Finland	Novartis Investigative Site	Tampere
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Clermont Ferrand Cedex
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Pessac
France	Novartis Investigative Site	St. Herblain
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Beelitz-Heilstaetten
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Stadtroda
Germany	Novartis Investigative Site	Tuebingen
Italy	Novartis Investigative Site	Lido di Camaiore
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma
Italy	Novartis Investigative Site	Roma
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Tochigi
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative SIte	Tokyo
Japan	Novartis Investigative Site	Toon
Japan	Novartis Investigative Site	Wakayama
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	San Sebastian

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Australia,  Canada,  Finland,  France,  Germany,  Italy,  Japan,  Spain, 

References & Publications (1)

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 stud — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score		12 weeks
Secondary	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
Secondary	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
Secondary	Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)		12 weeks
Secondary	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

External Links

•   Results for CAFQ056A2208 from the Novartis Clinical Trials website