Azilect® In Wearing-Off (AIWO)

NCT ID: NCT02384512

Last Updated: 2023-04-12

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

Total Enrollment

261 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in combination therapy with L-dopa and other parkinsonian medication.

Detailed Description

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The aim of the non-interventional study is to document efficacy and tolerability of rasagiline as a combination therapy in patients with wearing-off-/End-of-dose fluctuations and the effect of rasagiline on individual wearing-off symptoms, recognized by wearing-off questionnaire 32 (WOQ-32).

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Azilect®

AZILECT® 1mg Tablets

Intervention Type DRUG

Other Intervention Names

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Rasagiline

Eligibility Criteria

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Inclusion Criteria

* idiopathic Parkinson's disease based on the UK Brain Bank criteria,
* Wearing-off / end-of-dose akinesia
* at least 18 years old,
* written consent to participate in the study.

Exclusion:

* contraindications according to the SmPC of Azilect®,
* treatment with Azilect® in the past 3 months and / or
* suffering from a relevant cognitive impairment and therefore neither understand the patient information, nor can give their consent to participate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anfomed GmbH

INDUSTRY

Sponsor Role collaborator

Teva Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert, MD

Role: STUDY_DIRECTOR

Paracelsus Elena Klinik

Locations

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Teva Investigational Sites

Aalen, , Germany

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Achim, , Germany

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Altenburg, , Germany

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Altenholz, , Germany

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Alzenau in Unterfranken, , Germany

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Apolda, , Germany

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Aschaffenburg, , Germany

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Bad Honnef, , Germany

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Bad Kissingen, , Germany

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Bad Mergentheim, , Germany

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Bad Schwartau, , Germany

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Bad Waldsee, , Germany

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Bad Wörishofen, , Germany

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Bensheim, , Germany

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Bergisch Gladbach, , Germany

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Berlin, , Germany

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Bernburg, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Bockhorn, , Germany

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Bogen, , Germany

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Bonn, , Germany

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Butzbach, , Germany

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Buxtehude, , Germany

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Chemnitz, , Germany

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Cloppenburg, , Germany

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Cologne, , Germany

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Cottbus, , Germany

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Dessau, , Germany

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Dillingen, , Germany

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Düsseldorf, , Germany

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Eisleben Lutherstadt, , Germany

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Erbach im Odenwald, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Flensburg, , Germany

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Frankfurt, , Germany

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Fürth, , Germany

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Gadebusch, , Germany

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Gelsenkirchen, , Germany

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Gera, , Germany

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Gladenbach, , Germany

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Göppingen, , Germany

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Göttingen, , Germany

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Greifswald, , Germany

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Großbeeren, , Germany

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Grünstadt, , Germany

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Hagen, , Germany

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Halsbrücke, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidenheim, , Germany

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Herne, , Germany

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Hettstedt, , Germany

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Hildesheim, , Germany

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Hoppegarten, , Germany

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Ilmenau, , Germany

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Immenstadt im Allgäu, , Germany

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Iserlohn, , Germany

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Itzehoe, , Germany

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Jülich, , Germany

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Kaiserslautern, , Germany

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Karlstadt am Main, , Germany

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Kastellaun, , Germany

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Katzenelnbogen, , Germany

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Kaufbeuren, , Germany

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Kempten, , Germany

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Kiel, , Germany

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Kleve, , Germany

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Königsbrück, , Germany

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Krefeld, , Germany

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Ladenburg, , Germany

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Landshut, , Germany

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Lappersdorg, , Germany

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Lauf, , Germany

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Leer, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Limburg, , Germany

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Lingen, , Germany

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Lohr, , Germany

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Ludwigshafen, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Markkleeberg, , Germany

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Menden, , Germany

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Mittweida, , Germany

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Mönchengladbach, , Germany

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Mühlhausen, , Germany

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München, , Germany

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Naumburg, , Germany

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Neu-Ulm, , Germany

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Neuburg am Inn, , Germany

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Neunkirchen, , Germany

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Neupotz, , Germany

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Neusäß, , Germany

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Nuremberg, , Germany

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Oberhausen, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Ostfildern, , Germany

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Pulheim, , Germany

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Ravensburg, , Germany

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Regensburg, , Germany

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Ribnitz-Damgarten, , Germany

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Rostock, , Germany

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Rotenburg (Wümme), , Germany

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Saalouis, , Germany

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Sande, , Germany

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Schirgiswalkde-Kirschau, , Germany

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Schleiden, , Germany

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Schongau, , Germany

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Schwarzenbruck, , Germany

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Schweich, , Germany

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Schweinfurt, , Germany

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Schwerin, , Germany

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Schwetzingen, , Germany

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Seelow, , Germany

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Siegen, , Germany

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Sinsheim, , Germany

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Solingen, , Germany

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Sondershausen, , Germany

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Sprockhövel, , Germany

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Stade, , Germany

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Stralsund, , Germany

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Stuttgart, , Germany

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Treuenbrietzen, , Germany

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Troisdorg-Sieglar, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Varel, , Germany

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Vellmar, , Germany

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Weißenfels, , Germany

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Wismar, , Germany

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Wolfach, , Germany

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Wolfratshausen, , Germany

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Wuppertal, , Germany

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Zossen, , Germany

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Zwickau, , Germany

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Countries

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Germany

Other Identifiers

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TVP1012-CNS-40090

Identifier Type: -

Identifier Source: org_study_id

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