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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Pharma GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anfomed GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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