Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Novartis

Status and phase: Completed; Phase 2

Conditions: Levodopa; Parkinson Disease; Dyskinesia, Drug-Induced

Treatments: Drug: AFQ056

Study type: Interventional

Funder types: Industry

Identifiers

NCT01173731

2010-019418-25 (EudraCT Number)

CAFQ056A2217

Details and patient eligibility

About

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Enrollment: 66 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

66 participants in 1 patient group

AFQ056

Experimental group

Treatment:

Drug: AFQ056