Azilect® In Wearing-Off (AIWO)
AIWO
1 other identifier
observational
261
1 country
140
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Shorter than P25 for all trials
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedApril 12, 2023
April 1, 2023
11 months
March 4, 2015
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wearing-off Questionnaire-32 (WOQ-32)
Alterations of 32 different wearing-off symptoms (Patient questionnaire)
12 weeks
Secondary Outcomes (5)
WHO-5
12 weeks
GI-I
12 weeks
Columbia University Rating Scale (CURS)
12 weeks
Clinical global impression improvement (CGI-I)
12 weeks
Percentage of participants with adverse events
12 weeks
Interventions
Eligibility Criteria
Participants will be patients with Parkinson's disease in Germany
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teva Pharma GmbHlead
- Anfomed GmbHcollaborator
Study Sites (140)
Teva Investigational Sites
Aalen, Germany
Teva Investigational Sites
Achim, Germany
Teva Investigational Sites
Altenburg, Germany
Teva Investigational Sites
Altenholz, Germany
Teva Investigational Sites
Alzenau in Unterfranken, 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
Cologne, 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 Lutherstadt, Germany
Teva Investigational Sites
Erbach im Odenwald, 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
Göppingen, Germany
Teva Investigational Sites
Göttingen, Germany
Teva Investigational Sites
Greifswald, Germany
Teva Investigational Sites
Großbeeren, Germany
Teva Investigational Sites
Grünstadt, Germany
Teva Investigational Sites
Hagen, Germany
Teva Investigational Sites
Halsbrücke, Germany
Teva Investigational Sites
Hamburg, Germany
Teva Investigational Sites
Hanover, 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 im Allgäu, 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 am Main, 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
Königsbrück, Germany
Teva Investigational Sites
Krefeld, 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 am Inn, Germany
Teva Investigational Sites
Neunkirchen, Germany
Teva Investigational Sites
Neupotz, Germany
Teva Investigational Sites
Neusäß, Germany
Teva Investigational Sites
Nuremberg, 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 (Wümme), 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Expert, MD
Paracelsus Elena Klinik
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 10, 2015
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
April 12, 2023
Record last verified: 2023-04