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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888004
• Other study ID #: CAFQ056A2206
• Secondary ID: 2008-006270-15
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2009
• Last updated: April 15, 2016
• Start date: March 2009

Study information

• Verified date: April 2016
• 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: 28
• Est. primary completion date: August 2009
• 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, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• L-dopa Induced Dyskinesia
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• AFQ056

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Leun-Biskirchen
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Tubingen

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		20 days	No
Secondary	Safety and tolerability of administration of AFQ056 in combination with L-dopa		20 days	Yes