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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