Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Parkinson Disease Clinical Trial

Official title:

12-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: NCT01385592
• Other study ID #: CAFQ056A2222
• Secondary ID: 2011-002073-30
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• 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

• Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks

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) or evidence of dementia that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Disease
• Dyskinesias
• Movement Disorders
• Parkinson Disease
• Parkinsonian Disorders

Intervention

Drug:
• AFQ056

• Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Gatineau	Quebec
Canada	Novartis Investigative Site	London	Ontario
France	Novartis Investigative Site	Clermont-Ferrand Cedex 1
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Pessac
France	Novartis Investigative Site	Poitiers
Germany	Novartis Investigative Site	Beelitz-Heilstaetten
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Stadtroda
Germany	Novartis Investigative Site	Westerstede/Oldenburg
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Kaposvár
Hungary	Novartis Investigative Site	Szeged
Italy	Novartis Investigative Site	Bolzano	BZ
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Roma	RM
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	San Sebastian
Spain	Novartis Investigative Site	Sant Cugat	Barcelona
United States	Novartis Investigative Site	Englewood	Colorado
United States	Novartis Investigative Site	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile		12 weeks
Secondary	Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)		12 weeks
Secondary	Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)		12 weeks
Secondary	Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)		12 weeks
Secondary	Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )		12 weeks
Secondary	Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events		12 weeks

External Links

•   Results for CAFQ056A2222 from the Novartis Clinical Trials website