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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00582673

Collaborator

(none)

Enrollment

Locations

Arms

6.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: AFQ056 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AFQ056
Placebo Comparator: 2	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 1

Drug: AFQ056

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigator Site	Dresden	Germany
2	Novartis Investigator Site	Kassel	Germany
3	Novartis Investigator Site	Leun	Germany
4	Novartis Investigator Site	Marburg	Germany
5	Novartis Investigator Site	Tuebingen	Germany

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator: Novartis, Novartis investigative site

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00582673

Other Study ID Numbers:

CAFQ056A2203

First Posted:

Dec 28, 2007

Last Update Posted:

May 14, 2010

Last Verified:

May 1, 2010

Keywords provided by , ,

Parkinson's, L-dopa, dyskinesia

Additional relevant MeSH terms:

Parkinson Disease

Dyskinesias

Study Results

No Results Posted as of May 14, 2010