Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

Novartis

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: AFQ056 with L-dopa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092065

CAFQ056A2216

Details and patient eligibility

About

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

Enrollment: 23 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

AFQ056 100 mg (Bid)

Experimental group

Treatment:

Drug: AFQ056 with L-dopa

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo