Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Novartis

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease; Dyskinesias

Treatments: Drug: Placebo; Drug: AFQ056

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986414

EUDRACT number 2008-008712-98

CAFQ056A2208

Details and patient eligibility

About

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.

Enrollment: 260 estimated 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 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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260 participants in 6 patient groups, including a placebo group

AFQ056-10mg

Experimental group

Treatment:

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

AFQ056-25mg

Experimental group

Treatment:

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

AFQ056-50mg

Experimental group

Treatment:

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

AFQ056-75mg

Experimental group

Treatment:

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

AFQ056-100mg

Experimental group

Treatment:

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Drug: AFQ056

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo