Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

• Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; -dopa induced dyskinesias in patients with Parkinson's disease; MedDRA version: 14.1Level: PTClassification code 10043118Term: Tardive dyskinesiaSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2011-002073-30-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-06
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Outpatients with Parkinson`s disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months • Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

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) or evidence of dementia that may interfere with the study outcome evaluations Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified