Azilect® In Wearing-Off (AIWO)

Parkinson's Disease Clinical Trial

— AIWO  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384512
• Other study ID #: TVP1012-CNS-40090
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2023
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Azilect®
AZILECT® 1mg Tablets

Locations

Country	Name	City	State
Germany	Teva Investigational Sites	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	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	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	Köln
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
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

Sponsors (2)

Lead Sponsor	Collaborator
Teva Pharma GmbH	Anfomed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wearing-off Questionnaire-32 (WOQ-32)	Alterations of 32 different wearing-off symptoms (Patient questionnaire)	12 weeks
Secondary	WHO-5	Alterations of patient's Quality of life (patient questionnaire)	12 weeks
Secondary	GI-I	Self-Assessment of global improvement (patient questionnaire)	12 weeks
Secondary	Columbia University Rating Scale (CURS)	Alteration of PD symptoms (physician rated questionnaires)	12 weeks
Secondary	Clinical global impression improvement (CGI-I)	(physician rated questionnaires)	12 weeks
Secondary	Percentage of participants with adverse events		12 weeks