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

Parkinson's Disease Clinical Trial

Official title:

A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582673
• Other study ID #: CAFQ056A2203
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: May 13, 2010
• Start date: October 2007

Study information

• Verified date: May 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• AFQ056

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Dresden
Germany	Novartis Investigator Site	Kassel
Germany	Novartis Investigator Site	Leun
Germany	Novartis Investigator Site	Marburg
Germany	Novartis Investigator Site	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa		throughout the study
Secondary	Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa		throughout the study