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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: AFQ056
  • Drug: AFQ056
  • Drug: AFQ056
  • Drug: AFQ056
  • Drug: AFQ056
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: AFQ056-10mg
  • Experimental: AFQ056-25mg
  • Experimental: AFQ056-50mg
  • Experimental: AFQ056-75mg
  • Experimental: AFQ056-100mg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
    • Time Frame: 12 weeks

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Citations Reporting on Results

Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.

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