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Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

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. Identifier: NCT01173731
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : August 26, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Condition or disease Intervention/treatment Phase
Parkinson Disease Dyskinesia, Drug-Induced Levodopa Drug: AFQ056 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Study Start Date : October 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AFQ056 Drug: AFQ056

Primary Outcome Measures :
  1. Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). [ Time Frame: 3.5 years ]

Secondary Outcome Measures :
  1. Assessment of dyskinetic symptoms by change from baseline in mAIMS total score [ Time Frame: 3.5 years ]
  2. Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively [ Time Frame: 3.5 years ]

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.

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) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

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 identifier (NCT number): NCT01173731

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United States, California
Novartis Investigative Site
Sunnyvale, California, United States, 94089
United States, Colorado
Novartis Investigative Site
Englewood, Colorado, United States, 80113
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202
Australia, Victoria
Novartis Investigative Site
Heidelberg, Victoria, Australia, 3081
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada, K1G 4G3
Canada, Quebec
Novartis Investigative Site
Gatineau, Quebec, Canada, J9J 0A5
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2J2
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
Bochum, Germany, 44791
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Kassel, Germany, 34128
Novartis Investigative Site
Marburg, Germany, 35039
Novartis Investigative Site
Muenchen, Germany, 80804
Novartis Investigative Site
Stadtroda, Germany, 07646
Novartis Investigative Site
Tuebingen, Germany, 72076
Novartis Investigative Site
Lido di Camaiore, LU, Italy, 55041
Novartis Investigative Site
Roma, RM, Italy, 00163
Novartis Investigative Site
Napoli, Italy, 80131
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01173731    
Other Study ID Numbers: CAFQ056A2217
2010-019418-25 ( EudraCT Number )
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Parkinson Disease
involuntary movement
motor complication
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders