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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

AFQ056

Placebo

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's, L-dopa, dyskinesia

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site
Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00582673

First Posted

December 21, 2007

Last Updated

May 13, 2010

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00582673

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's, L-dopa, dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

AFQ056

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

throughout the study

Secondary Outcome Measure Information:

Title

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

Time Frame

throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis investigative site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigator Site

City

Dresden

Country

Germany

Facility Name

Novartis Investigator Site

City

Kassel

Country

Germany

Facility Name

Novartis Investigator Site

City

Leun

Country

Germany

Facility Name

Novartis Investigator Site

City

Marburg

Country

Germany

Facility Name

Novartis Investigator Site

City

Tuebingen

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21484867

Citation

Berg D, Godau J, Trenkwalder C, Eggert K, Csoti I, Storch A, Huber H, Morelli-Canelo M, Stamelou M, Ries V, Wolz M, Schneider C, Di Paolo T, Gasparini F, Hariry S, Vandemeulebroecke M, Abi-Saab W, Cooke K, Johns D, Gomez-Mancilla B. AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Mov Disord. 2011 Jun;26(7):1243-50. doi: 10.1002/mds.23616. Epub 2011 Apr 11.

Results Reference

derived

Learn more about this trial

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

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