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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385592
First Posted: June 30, 2011
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Condition Intervention Phase
Dyskinesias Parkinson Disease Movement Disorders Parkinsonian Disorders Drug: AFQ056 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) [ Time Frame: 12 weeks ]
  • Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) [ Time Frame: 12 weeks ]
  • Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) [ Time Frame: 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 ) [ Time Frame: 12 weeks ]
  • Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events [ Time Frame: 12 weeks ]

Enrollment: 78
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFQ056 100 mg Drug: AFQ056
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385592


Locations
United States, California
Novartis Investigative Site
Sunnyvale, California, United States, 94089
United States, Colorado
Novartis Investigative Site
Englewood, Colorado, United States, 80113
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada, N6A 4G5
Canada, Quebec
Novartis Investigative Site
Gatineau, Quebec, Canada, J9J 0A5
France
Novartis Investigative Site
Clermont-Ferrand Cedex 1, France, 63003
Novartis Investigative Site
Lille Cedex, France, 59037
Novartis Investigative Site
Pessac, France, 33604
Novartis Investigative Site
Poitiers, France, 86021
Germany
Novartis Investigative Site
Beelitz-Heilstaetten, Germany, 14547
Novartis Investigative Site
Berlin, Germany, 12163
Novartis Investigative Site
Bochum, Germany, 44791
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Kassel, Germany, 34128
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Muenchen, Germany, 80804
Novartis Investigative Site
München, Germany, 81675
Novartis Investigative Site
Stadtroda, Germany, 07646
Novartis Investigative Site
Westerstede/Oldenburg, Germany, 26655
Hungary
Novartis Investigative Site
Budapest, Hungary, 1085
Novartis Investigative Site
Kaposvár, Hungary, 7400
Novartis Investigative Site
Szeged, Hungary, H-6725
Italy
Novartis Investigative Site
Bolzano, BZ, Italy, 39100
Novartis Investigative Site
Pisa, PI, Italy, 56126
Novartis Investigative Site
Roma, RM, Italy, 00163
Spain
Novartis Investigative Site
Sant Cugat, Barcelona, Spain, 08190
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08036
Novartis Investigative Site
Madrid, Spain, 28006
Novartis Investigative Site
San Sebastian, Spain, 20014
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01385592     History of Changes
Other Study ID Numbers: CAFQ056A2222
2011-002073-30 ( EudraCT Number )
First Submitted: June 28, 2011
First Posted: June 30, 2011
Last Update Posted: April 25, 2016
Last Verified: March 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Parkinson Disease
L-dopa
Levodopa
Dyskinesia
Anti-Dyskinesia Agents

Additional relevant MeSH terms:
Parkinsonian Disorders
Disease
Parkinson Disease
Dyskinesias
Movement Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs