Azilect® In Wearing-Off (AIWO) (AIWO)

April 11, 2023 updated by: Teva Pharma GmbH

Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson's Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

261

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aalen, Germany
        • Teva Investigational Sites
      • Achim, Germany
        • Teva Investigational Sites
      • Altenburg, Germany
        • Teva Investigational Sites
      • Altenholz, Germany
        • Teva Investigational Sites
      • Alzenau, Germany
        • Teva Investigational Sites
      • Apolda, Germany
        • Teva Investigational Sites
      • Aschaffenburg, Germany
        • Teva Investigational Sites
      • Bad Honnef, Germany
        • Teva Investigational Sites
      • Bad Kissingen, Germany
        • Teva Investigational Sites
      • Bad Mergentheim, Germany
        • Teva Investigational Sites
      • Bad Schwartau, Germany
        • Teva Investigational Sites
      • Bad Waldsee, Germany
        • Teva Investigational Sites
      • Bad Wörishofen, Germany
        • Teva Investigational Sites
      • Bensheim, Germany
        • Teva Investigational Sites
      • Bergisch Gladbach, Germany
        • Teva Investigational Sites
      • Berlin, Germany
        • Teva Investigational Sites
      • Bernburg, Germany
        • Teva Investigational Sites
      • Bielefeld, Germany
        • Teva Investigational Sites
      • Bochum, Germany
        • Teva Investigational Sites
      • Bockhorn, Germany
        • Teva Investigational Sites
      • Bogen, Germany
        • Teva Investigational Sites
      • Bonn, Germany
        • Teva Investigational Sites
      • Butzbach, Germany
        • Teva Investigational Sites
      • Buxtehude, Germany
        • Teva Investigational Sites
      • Chemnitz, Germany
        • Teva Investigational Sites
      • Cloppenburg, Germany
        • Teva Investigational Sites
      • Cottbus, Germany
        • Teva Investigational Sites
      • Dessau, Germany
        • Teva Investigational Sites
      • Dillingen, Germany
        • Teva Investigational Sites
      • Düsseldorf, Germany
        • Teva Investigational Sites
      • Eisleben, Germany
        • Teva Investigational Sites
      • Erbach, Germany
        • Teva Investigational Sites
      • Erfurt, Germany
        • Teva Investigational Sites
      • Essen, Germany
        • Teva Investigational Sites
      • Flensburg, Germany
        • Teva Investigational Sites
      • Frankfurt, Germany
        • Teva Investigational Sites
      • Fürth, Germany
        • Teva Investigational Sites
      • Gadebusch, Germany
        • Teva Investigational Sites
      • Gelsenkirchen, Germany
        • Teva Investigational Sites
      • Gera, Germany
        • Teva Investigational Sites
      • Gladenbach, Germany
        • Teva Investigational Sites
      • Greifswald, Germany
        • Teva Investigational Sites
      • Großbeeren, Germany
        • Teva Investigational Sites
      • Grünstadt, Germany
        • Teva Investigational Sites
      • Göppingen, Germany
        • Teva Investigational Sites
      • Göttingen, Germany
        • Teva Investigational Sites
      • Hagen, Germany
        • Teva Investigational Sites
      • Halsbrücke, Germany
        • Teva Investigational Sites
      • Hamburg, Germany
        • Teva Investigational Sites
      • Hannover, Germany
        • Teva Investigational Sites
      • Heidenheim, Germany
        • Teva Investigational Sites
      • Herne, Germany
        • Teva Investigational Sites
      • Hettstedt, Germany
        • Teva Investigational Sites
      • Hildesheim, Germany
        • Teva Investigational Sites
      • Hoppegarten, Germany
        • Teva Investigational Sites
      • Ilmenau, Germany
        • Teva Investigational Sites
      • Immenstadt, Germany
        • Teva Investigational Sites
      • Iserlohn, Germany
        • Teva Investigational Sites
      • Itzehoe, Germany
        • Teva Investigational Sites
      • Jülich, Germany
        • Teva Investigational Sites
      • Kaiserslautern, Germany
        • Teva Investigational Sites
      • Karlstadt, Germany
        • Teva Investigational Sites
      • Kastellaun, Germany
        • Teva Investigational Sites
      • Katzenelnbogen, Germany
        • Teva Investigational Sites
      • Kaufbeuren, Germany
        • Teva Investigational Sites
      • Kempten, Germany
        • Teva Investigational Sites
      • Kiel, Germany
        • Teva Investigational Sites
      • Kleve, Germany
        • Teva Investigational Sites
      • Krefeld, Germany
        • Teva Investigational Sites
      • Köln, Germany
        • Teva Investigational Sites
      • Königsbrück, Germany
        • Teva Investigational Sites
      • Ladenburg, Germany
        • Teva Investigational Sites
      • Landshut, Germany
        • Teva Investigational Sites
      • Lappersdorg, Germany
        • Teva Investigational Sites
      • Lauf, Germany
        • Teva Investigational Sites
      • Leer, Germany
        • Teva Investigational Sites
      • Leipzig, Germany
        • Teva Investigational Sites
      • Leverkusen, Germany
        • Teva Investigational Sites
      • Limburg, Germany
        • Teva Investigational Sites
      • Lingen, Germany
        • Teva Investigational Sites
      • Lohr, Germany
        • Teva Investigational Sites
      • Ludwigshafen, Germany
        • Teva Investigational Sites
      • Magdeburg, Germany
        • Teva Investigational Sites
      • Mainz, Germany
        • Teva Investigational Sites
      • Mannheim, Germany
        • Teva Investigational Sites
      • Markkleeberg, Germany
        • Teva Investigational Sites
      • Menden, Germany
        • Teva Investigational Sites
      • Mittweida, Germany
        • Teva Investigational Sites
      • Mönchengladbach, Germany
        • Teva Investigational Sites
      • Mühlhausen, Germany
        • Teva Investigational Sites
      • München, Germany
        • Teva Investigational Sites
      • Naumburg, Germany
        • Teva Investigational Sites
      • Neu-Ulm, Germany
        • Teva Investigational Sites
      • Neuburg, Germany
        • Teva Investigational Sites
      • Neunkirchen, Germany
        • Teva Investigational Sites
      • Neupotz, Germany
        • Teva Investigational Sites
      • Neusäß, Germany
        • Teva Investigational Sites
      • Nürnberg, Germany
        • Teva Investigational Sites
      • Oberhausen, Germany
        • Teva Investigational Sites
      • Oldenburg, Germany
        • Teva Investigational Sites
      • Osnabrück, Germany
        • Teva Investigational Sites
      • Ostfildern, Germany
        • Teva Investigational Sites
      • Pulheim, Germany
        • Teva Investigational Sites
      • Ravensburg, Germany
        • Teva Investigational Sites
      • Regensburg, Germany
        • Teva Investigational Sites
      • Ribnitz-Damgarten, Germany
        • Teva Investigational Sites
      • Rostock, Germany
        • Teva Investigational Sites
      • Rotenburg, Germany
        • Teva Investigational Sites
      • Saalouis, Germany
        • Teva Investigational Sites
      • Sande, Germany
        • Teva Investigational Sites
      • Schirgiswalkde-Kirschau, Germany
        • Teva Investigational Sites
      • Schleiden, Germany
        • Teva Investigational Sites
      • Schongau, Germany
        • Teva Investigational Sites
      • Schwarzenbruck, Germany
        • Teva Investigational Sites
      • Schweich, Germany
        • Teva Investigational Sites
      • Schweinfurt, Germany
        • Teva Investigational Sites
      • Schwerin, Germany
        • Teva Investigational Sites
      • Schwetzingen, Germany
        • Teva Investigational Sites
      • Seelow, Germany
        • Teva Investigational Sites
      • Siegen, Germany
        • Teva Investigational Sites
      • Sinsheim, Germany
        • Teva Investigational Sites
      • Solingen, Germany
        • Teva Investigational Sites
      • Sondershausen, Germany
        • Teva Investigational Sites
      • Sprockhövel, Germany
        • Teva Investigational Sites
      • Stade, Germany
        • Teva Investigational Sites
      • Stralsund, Germany
        • Teva Investigational Sites
      • Stuttgart, Germany
        • Teva Investigational Sites
      • Treuenbrietzen, Germany
        • Teva Investigational Sites
      • Troisdorg-Sieglar, Germany
        • Teva Investigational Sites
      • Tübingen, Germany
        • Teva Investigational Sites
      • Ulm, Germany
        • Teva Investigational Sites
      • Varel, Germany
        • Teva Investigational Sites
      • Vellmar, Germany
        • Teva Investigational Sites
      • Weißenfels, Germany
        • Teva Investigational Sites
      • Wismar, Germany
        • Teva Investigational Sites
      • Wolfach, Germany
        • Teva Investigational Sites
      • Wolfratshausen, Germany
        • Teva Investigational Sites
      • Wuppertal, Germany
        • Teva Investigational Sites
      • Zossen, Germany
        • Teva Investigational Sites
      • Zwickau, Germany
        • Teva Investigational Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants will be patients with Parkinson's disease in Germany

Description

Inclusion:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wearing-off Questionnaire-32 (WOQ-32)
Time Frame: 12 weeks
Alterations of 32 different wearing-off symptoms (Patient questionnaire)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHO-5
Time Frame: 12 weeks
Alterations of patient's Quality of life (patient questionnaire)
12 weeks
GI-I
Time Frame: 12 weeks
Self-Assessment of global improvement (patient questionnaire)
12 weeks
Columbia University Rating Scale (CURS)
Time Frame: 12 weeks
Alteration of PD symptoms (physician rated questionnaires)
12 weeks
Clinical global impression improvement (CGI-I)
Time Frame: 12 weeks
(physician rated questionnaires)
12 weeks
Percentage of participants with adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Pharma GmbH

Collaborators

Anfomed GmbH

Investigators

  • Study Director: Medical Expert, MD, Paracelsus-Elena-Klinik Kassel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVP1012-CNS-40090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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