Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

• Conditions: -dopa induced dyskinesias in patients with Parkinson's disease; MedDRA version: 14.1Level: HLTClassification code 10013929Term: Dyskinesias and movement disorders NECSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004378-27-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-02
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

- Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol - Outpatients - Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements 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 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

-Atypical or secondary form of Parkinson's disease -History of surgical treatment for PD including deep brain stimulation -Advanced, severe, or unstable disease (other than PD) -History of malignancy -Evidence of dementia -Untreated/ineffectively treated mental disorders -Treatment with certain prohibited medications -Abnormal lab values or heart abnormalities -Pregnant or nursing women Other protocol-defined exclusion criteria may apply

Study & Design

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