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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01385592
Other study ID # CAFQ056A2222
Secondary ID 2011-002073-30
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date September 2012

Study information

Verified date March 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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