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Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease, Dyskinesias

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AFQ056

Placebo

About this trial

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

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months

Exclusion Criteria:

Surgical treatment for PD
Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

AFQ056-10mg

AFQ056-25mg

AFQ056-50mg

AFQ056-75mg

AFQ056-100mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score

Secondary Outcome Measures

Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score

Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change

Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)

Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD

Full Information

NCT ID

NCT00986414

First Posted

September 29, 2009

Last Updated

February 20, 2017

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00986414

Brief Title

Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Official Title

13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2010 (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 phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

6. Conditions and Keywords

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

Parkinson Disease, Dyskinesias

Keywords

Parkinson Disease, L-dopa, Levodopa, dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AFQ056-10mg

Arm Type

Experimental

Arm Title

AFQ056-25mg

Arm Type

Experimental

Arm Title

AFQ056-50mg

Arm Type

Experimental

Arm Title

AFQ056-75mg

Arm Type

Experimental

Arm Title

AFQ056-100mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

AFQ056

Intervention Type

Drug

Intervention Name(s)

AFQ056

Intervention Type

Drug

Intervention Name(s)

AFQ056

Intervention Type

Drug

Intervention Name(s)

AFQ056

Intervention Type

Drug

Intervention Name(s)

AFQ056

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score

Time Frame

12 weeks

Title

Time Frame

12 weeks

Title

Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)

Time Frame

12 weeks

Title

Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months Exclusion Criteria: Surgical treatment for PD Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations 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

East Gosford

ZIP/Postal Code

2250

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

ZIP/Postal Code

3181

Country

Australia

Facility Name

Novartis Investigational Site

City

Westmead

ZIP/Postal Code

NSW 2145

Country

Australia

Facility Name

Clinique Neuro-Outaouais

City

Gatineau

ZIP/Postal Code

J9J 0A5

Country

Canada

Facility Name

Recherches Pembina, Inc

City

Greenfield Park

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Parkinson's and Neurodegenerative Disorders Clinic

City

Ottawa

ZIP/Postal Code

K1G 4G3

Country

Canada

Facility Name

Quebec Memory & Motor Skills Disorders Clinic

City

Quebec

ZIP/Postal Code

G1R 3X5

Country

Canada

Facility Name

Toronto Western Hospital, UHN

City

Toronto

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

ZIP/Postal Code

V6T 2B5

Country

Canada

Facility Name

Novartis Investigative Site

City

Kuopio

Country

Finland

Facility Name

Novartis Investigative Site

City

Lahti

ZIP/Postal Code

15110

Country

Finland

Facility Name

Novartis Investigative Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Clermont Ferrand Cedex

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

St. Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Beelitz-Heilstaetten

ZIP/Postal Code

14547

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13088

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34128

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80804

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtroda

ZIP/Postal Code

07646

Country

Germany

Facility Name

Novartis Investigative Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Lido di Camaiore

ZIP/Postal Code

55041

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

ZIP/Postal Code

00163

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

ZIP/Postal Code

00185

Country

Italy

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Novartis Investigative Site

City

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

136-0075

Country

Japan

Facility Name

Novartis Investigative SIte

City

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

Novartis Investigative Site

City

Toon

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Novartis Investigative Site

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08190

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23853029

Citation

Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.

Results Reference

result

Learn more about this trial

Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

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Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Parkinson Disease, Dyskinesias

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial