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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

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ClinicalTrials.gov Identifier: NCT00986414
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson Disease Dyskinesias Drug: AFQ056 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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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

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 ClinicalTrials.gov identifier (NCT number): NCT00986414


  Show 47 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00986414     History of Changes
Other Study ID Numbers: CAFQ056A2208
EUDRACT number 2008-008712-98
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Parkinson Disease
L-dopa
Levodopa
dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
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