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Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

NCT ID: NCT01491932

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

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).

Detailed Description

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Conditions

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Dyskinesias Parkinson Disease Movement Disorders Parkinsonian Disorders Anti-Dyskinesia Agents

Keywords

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Parkinson Disease L-dopa Levodopa Dyskinesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AFQ056

Patients entering the study will be titrated to target dose of AFQ056 twice daily or the highest tolerated dose at weekly intervals.

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

AFQ056 will be supplied as oral capsules.

Interventions

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AFQ056

AFQ056 will be supplied as oral capsules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
* Outpatients
* Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements

Exclusion Criteria

* Atypical or secondary form of Parkinson's disease
* History of surgical treatment for PD including deep brain stimulation
* Advanced, severe, or unstable disease (other than PD)
* History of malignancy
* Evidence of dementia
* Untreated/ineffectively treated mental disorders
* Treatment with certain prohibited medications
* Abnormal lab values or heart abnormalities
* Pregnant or nursing women
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

Englewood, Colorado, United States

Site Status

Novartis Investigative Site

Kansas City, Kansas, United States

Site Status

Novartis Investigative Site

Milwaukee, Wisconsin, United States

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Novartis Investigative Site

Innsbruck, , Austria

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Novartis Investigative Site

Linz, , Austria

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Novartis Investigative Site

Vienna, , Austria

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Novartis Investigative Site

London, Ontario, Canada

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Novartis Investigative Site

Clermont-Ferrand, , France

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Novartis Investigative Site

Lille, , France

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Novartis Investigative Site

Pessac, , France

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Novartis Investigative Site

Beelitz-Heilstätten, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Bochum, , Germany

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Novartis Investigative Site

Kassel, , Germany

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Novartis Investigative Site

Leipzig, , Germany

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Novartis Investigative Site

München, , Germany

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Novartis Investigative Site

Stadtroda, , Germany

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Novartis Investigative Site

Westerstede/Oldenburg, , Germany

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Novartis Investigative Site

Kaposvár, , Hungary

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Novartis Investigative Site

Szeged, , Hungary

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Novartis Investigative Site

Brescia, BS, Italy

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Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

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Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

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Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Donostia / San Sebastian, Basque Country, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

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Novartis Investigative Site

Sant Cugat del Vallès, Catalonia, Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Bern, , Switzerland

Site Status

Countries

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Turkey (Türkiye) United States Austria Canada France Germany Hungary Italy Slovakia Spain Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12843

Results from CAFQ056A2299 from the Novartis Clinical Trial Results website

Other Identifiers

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2011-004378-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAFQ056A2299

Identifier Type: -

Identifier Source: org_study_id