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Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 29, 2009
Last updated: February 20, 2017
Last verified: February 2017
This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

Condition Intervention Phase
Parkinson Disease Dyskinesias 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: 13-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:
  • Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score [ Time Frame: 12 weeks ]
  • Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change [ Time Frame: 12 weeks ]
  • Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) [ Time Frame: 12 weeks ]
  • Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD [ Time Frame: 12 weeks ]

Estimated Enrollment: 260
Study Start Date: September 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFQ056-10mg Drug: AFQ056
Experimental: AFQ056-25mg Drug: AFQ056
Experimental: AFQ056-50mg Drug: AFQ056
Experimental: AFQ056-75mg Drug: AFQ056
Experimental: AFQ056-100mg Drug: AFQ056
Placebo Comparator: Placebo Drug: Placebo


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

Inclusion Criteria:

  • Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00986414

  Show 47 Study Locations
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT00986414     History of Changes
Other Study ID Numbers: CAFQ056A2208
EUDRACT number 2008-008712-98
Study First Received: September 29, 2009
Last Updated: February 20, 2017

Keywords provided by Novartis:
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 22, 2017