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

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

May 9, 2008

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: throughout the study ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00582673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: throughout the study ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: AFQ056
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00582673

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CAFQ056A2203

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Novartis

Novartis investigative site

Information Provided By

Novartis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP