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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo; Drug: AFQ056

• Registration Number: NCT00582673
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-28
• Primary Completion: 2008-05
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-13
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	AFQ056	-

Primary Outcome Measures

Name	Time	Method
Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa	throughout the study

Secondary Outcome Measures

Name	Time	Method
Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇩🇪 Tuebingen, Germany