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

Primary Purpose

Parkinson's Disease, L-dopa Induced Dyskinesia

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 Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

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

Safety and tolerability of administration of AFQ056 in combination with L-dopa

Full Information

NCT ID

NCT00888004

First Posted

April 23, 2009

Last Updated

April 15, 2016

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00888004

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

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, L-dopa Induced Dyskinesia

Keywords

Parkinson's, L-dopa, dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Title

Placebo

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

20 days

Secondary Outcome Measure Information:

Title

Safety and tolerability of administration of AFQ056 in combination with L-dopa

Time Frame

20 days

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 Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Dresden

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

Country

Germany

Facility Name

Novartis Investigative Site

City

Leun-Biskirchen

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Tubingen

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

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

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