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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

NCT ID: NCT00986414

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease Dyskinesias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AFQ056-10mg

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

AFQ056-25mg

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

AFQ056-50mg

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

AFQ056-75mg

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

AFQ056-100mg

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AFQ056

Intervention Type DRUG

AFQ056

Intervention Type DRUG

AFQ056

Intervention Type DRUG

AFQ056

Intervention Type DRUG

AFQ056

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

East Gosford, , Australia

Site Status

Novartis Investigative Site

Heidelberg, , Australia

Site Status

Novartis Investigative Site

Melbourne, , Australia

Site Status

Novartis Investigative Site

Parkville, , Australia

Site Status

Novartis Investigational Site

Westmead, , Australia

Site Status

Quebec Memory & Motor Skills Disorders Clinic

Québec, Quebec, Canada

Site Status

Clinique Neuro-Outaouais

Gatineau, , Canada

Site Status

Recherches Pembina, Inc

Greenfield Park, , Canada

Site Status

Novartis Investigative Site

Montreal, , Canada

Site Status

Parkinson's and Neurodegenerative Disorders Clinic

Ottawa, , Canada

Site Status

Toronto Western Hospital, UHN

Toronto, , Canada

Site Status

Novartis Investigative Site

Vancouver, , Canada

Site Status

Novartis Investigative Site

Kuopio, , Finland

Site Status

Novartis Investigative Site

Lahti, , Finland

Site Status

Novartis Investigative Site

Oulu, , Finland

Site Status

Novartis Investigative Site

Tampere, , Finland

Site Status

Novartis Investigative Site

Turku, , Finland

Site Status

Novartis Investigative Site

Clermont-Ferrand, , France

Site Status

Novartis Investigative Site

Lille, , France

Site Status

Novartis Investigative Site

Pessac, , France

Site Status

Novartis Investigative Site

Saint-Herblain, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Beelitz-Heilstätten, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis Investigative Site

Marburg, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Stadtroda, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Novartis Investigative Site

Lido di Camaiore, , Italy

Site Status

Novartis Investigative Site

Napoli, , Italy

Site Status

Novartis Investigative Site

Roma, , Italy

Site Status

Novartis Investigative Site

Roma, , Italy

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Tochigi, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative SIte

Tokyo, , Japan

Site Status

Novartis Investigative Site

Tōon, , Japan

Site Status

Novartis Investigative Site

Wakayama, , Japan

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Donostia / San Sebastian, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Countries

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Australia Canada Finland France Germany Italy Japan Spain

References

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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.

Reference Type RESULT
PMID: 23853029 (View on PubMed)

Other Identifiers

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EUDRACT number 2008-008712-98

Identifier Type: -

Identifier Source: secondary_id

CAFQ056A2208

Identifier Type: -

Identifier Source: org_study_id

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