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

Novartis

Status and phase: Completed; Phase 2

Conditions: Parkinsonian Disorders; Movement Disorders; Parkinson Disease; Dyskinesias

Treatments: Drug: AFQ056; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01385592

2011-002073-30 (EudraCT Number)

CAFQ056A2222

Details and patient eligibility

About

This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Enrollment: 78 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
• Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks

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 inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

AFQ056 100 mg

Experimental group

Treatment:

Drug: AFQ056

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo