Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
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
2 other identifiers
interventional
78
7 countries
28
Brief Summary
This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 23, 2020
March 1, 2016
10 months
June 28, 2011
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
12 weeks
Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)
12 weeks
Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)
12 weeks
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
Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events
12 weeks
Study Arms (2)
AFQ056 100 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Novartis Investigative Site
Sunnyvale, California, 94089, United States
Novartis Investigative Site
Englewood, Colorado, 80113, United States
Novartis Investigative Site
London, Ontario, N6A 4G5, Canada
Novartis Investigative Site
Gatineau, Quebec, J9J 0A5, Canada
Novartis Investigative Site
Clermont-Ferrand, 63003, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Beelitz-Heilstätten, 14547, Germany
Novartis Investigative Site
Berlin, 12163, Germany
Novartis Investigative Site
Bochum, 44791, Germany
Novartis Investigative Site
Düsseldorf, 40225, Germany
Novartis Investigative Site
Kassel, 34128, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
München, 80804, Germany
Novartis Investigative Site
München, 81675, Germany
Novartis Investigative Site
Stadtroda, 07646, Germany
Novartis Investigative Site
Westerstede/Oldenburg, 26655, Germany
Novartis Investigative Site
Budapest, 1085, Hungary
Novartis Investigative Site
Kaposvár, 7400, Hungary
Novartis Investigative Site
Szeged, H-6725, Hungary
Novartis Investigative Site
Bolzano, BZ, 39100, Italy
Novartis Investigative Site
Pisa, PI, 56126, Italy
Novartis Investigative Site
Roma, RM, 00163, Italy
Novartis Investigative Site
Sant Cugat del Vallès, Barcelona, 08190, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Donostia / San Sebastian, 20014, Spain
Novartis Investigative Site
Madrid, 28006, Spain
Related Publications (1)
Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.
PMID: 27214258DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
June 30, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 23, 2020
Record last verified: 2016-03