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Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

NCT ID: NCT01173731

Last Updated: 2020-12-23

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Detailed Description

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Conditions

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Parkinson Disease Dyskinesia, Drug-Induced Levodopa

Keywords

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Parkinson Disease L-dopa Levodopa Dyskinesia involuntary movement motor complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AFQ056

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

Interventions

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AFQ056

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

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

Sunnyvale, California, United States

Site Status

Novartis Investigative Site

Englewood, Colorado, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Heidelberg, Victoria, Australia

Site Status

Novartis Investigative Site

Parkville, Victoria, Australia

Site Status

Novartis Investigative Site

Prahran, Victoria, Australia

Site Status

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status

Novartis Investigative Site

Gatineau, Quebec, Canada

Site Status

Novartis Investigative Site

Greenfield Park, Quebec, Canada

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

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, LU, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Napoli, , Italy

Site Status

Countries

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Finland Spain United States Australia Canada France Germany Italy

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12724

Results for CAFQ056A2217 from the Novartis Clinical Trials Website

Other Identifiers

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2010-019418-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAFQ056A2217

Identifier Type: -

Identifier Source: org_study_id