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

Phase 2

Completed

• Conditions: L-dopa Induced Dyskinesia; Parkinson's Disease
• Interventions: Drug: Placebo; Drug: AFQ056

• Registration Number: NCT00888004
• 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: 2009-03
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Primary Completion: 2009-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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
Placebo	Placebo	-
Active	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	20 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of administration of AFQ056 in combination with L-dopa	20 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Tubingen, Germany