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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01385592
First received: June 28, 2011
Last updated: December 6, 2012
Last verified: December 2012
  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: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01385592     History of Changes
Other Study ID Numbers: CAFQ056A2222, 2011-002073-30
Study First Received: June 28, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ministry of Health
France: Ministry of Health
Italy: Ministry of Health
Hungary: National Institute of Pharmacy
Spain: Ministry of Health

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

Additional relevant MeSH terms:
Parkinson Disease
Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Dyskinesias
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014