Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa

Novartis

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: AFQ056; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00582673

CAFQ056A2203

Details and patient eligibility

About

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Enrollment: 31 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Parkinson's Disease
• Patients with L-dopa induced dyskinesia for at least 3 months
• Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion criteria

• History of severe allergy to food or drugs
• Very low or high body weight.
• Prior surgery for Parkinson's Disease
• Smokers

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AFQ056

2

Placebo Comparator group

Treatment:

Drug: Placebo