Clinical trial NCT02384512: Azilect® In Wearing-Off (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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
akinesia
Azilect®
Rasagiline
Combination therapy with L-dopa
Wearing-off Questionnaire-32
Quality of life
Daily practice
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Anfomed GmbH
First posted: 2015-03-10
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be patients with Parkinson's disease in Germany

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Wearing-off Questionnaire-32 (WOQ-32)
timeFrame: 12 weeks
Secondary outcomes:
measure: WHO-5
timeFrame: 12 weeks
measure: GI-I
timeFrame: 12 weeks
measure: Columbia University Rating Scale (CURS)
timeFrame: 12 weeks
measure: Clinical global impression improvement (CGI-I)
timeFrame: 12 weeks
measure: Percentage of participants with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Teva Investigational Sites
city: Achim
country: Germany
facility: Teva Investigational Sites
city: Altenburg
country: Germany
facility: Teva Investigational Sites
city: Altenholz
country: Germany
facility: Teva Investigational Sites
city: Alzenau
country: Germany
facility: Teva Investigational Sites
city: Apolda
country: Germany
facility: Teva Investigational Sites
city: Aschaffenburg
country: Germany
facility: Teva Investigational Sites
city: Bad Honnef
country: Germany
facility: Teva Investigational Sites
city: Bad Kissingen
country: Germany
facility: Teva Investigational Sites
city: Bad Mergentheim
country: Germany
facility: Teva Investigational Sites
city: Bad Schwartau
country: Germany
facility: Teva Investigational Sites
city: Bad Waldsee
country: Germany
facility: Teva Investigational Sites
city: Bad Wörishofen
country: Germany
facility: Teva Investigational Sites
city: Bensheim
country: Germany
facility: Teva Investigational Sites
city: Bergisch Gladbach
country: Germany
facility: Teva Investigational Sites
city: Berlin
country: Germany
facility: Teva Investigational Sites
city: Bernburg
country: Germany
facility: Teva Investigational Sites
city: Bielefeld
country: Germany
facility: Teva Investigational Sites
city: Bochum
country: Germany
facility: Teva Investigational Sites
city: Bockhorn
country: Germany
facility: Teva Investigational Sites
city: Bogen
country: Germany
facility: Teva Investigational Sites
city: Bonn
country: Germany
facility: Teva Investigational Sites
city: Butzbach
country: Germany
facility: Teva Investigational Sites
city: Buxtehude
country: Germany
facility: Teva Investigational Sites
city: Chemnitz
country: Germany
facility: Teva Investigational Sites
city: Cloppenburg
country: Germany
facility: Teva Investigational Sites
city: Cottbus
country: Germany
facility: Teva Investigational Sites
city: Dessau
country: Germany
facility: Teva Investigational Sites
city: Dillingen
country: Germany
facility: Teva Investigational Sites
city: Düsseldorf
country: Germany
facility: Teva Investigational Sites
city: Eisleben
country: Germany
facility: Teva Investigational Sites
city: Erbach
country: Germany
facility: Teva Investigational Sites
city: Erfurt
country: Germany
facility: Teva Investigational Sites
city: Essen
country: Germany
facility: Teva Investigational Sites
city: Flensburg
country: Germany
facility: Teva Investigational Sites
city: Frankfurt
country: Germany
facility: Teva Investigational Sites
city: Fürth
country: Germany
facility: Teva Investigational Sites
city: Gadebusch
country: Germany
facility: Teva Investigational Sites
city: Gelsenkirchen
country: Germany
facility: Teva Investigational Sites
city: Gera
country: Germany
facility: Teva Investigational Sites
city: Gladenbach
country: Germany
facility: Teva Investigational Sites
city: Greifswald
country: Germany
facility: Teva Investigational Sites
city: Großbeeren
country: Germany
facility: Teva Investigational Sites
city: Grünstadt
country: Germany
facility: Teva Investigational Sites
city: Göppingen
country: Germany
facility: Teva Investigational Sites
city: Göttingen
country: Germany
facility: Teva Investigational Sites
city: Hagen
country: Germany
facility: Teva Investigational Sites
city: Halsbrücke
country: Germany
facility: Teva Investigational Sites
city: Hamburg
country: Germany
facility: Teva Investigational Sites
city: Hannover
country: Germany
facility: Teva Investigational Sites
city: Heidenheim
country: Germany
facility: Teva Investigational Sites
city: Herne
country: Germany
facility: Teva Investigational Sites
city: Hettstedt
country: Germany
facility: Teva Investigational Sites
city: Hildesheim
country: Germany
facility: Teva Investigational Sites
city: Hoppegarten
country: Germany
facility: Teva Investigational Sites
city: Ilmenau
country: Germany
facility: Teva Investigational Sites
city: Immenstadt
country: Germany
facility: Teva Investigational Sites
city: Iserlohn
country: Germany
facility: Teva Investigational Sites
city: Itzehoe
country: Germany
facility: Teva Investigational Sites
city: Jülich
country: Germany
facility: Teva Investigational Sites
city: Kaiserslautern
country: Germany
facility: Teva Investigational Sites
city: Karlstadt
country: Germany
facility: Teva Investigational Sites
city: Kastellaun
country: Germany
facility: Teva Investigational Sites
city: Katzenelnbogen
country: Germany
facility: Teva Investigational Sites
city: Kaufbeuren
country: Germany
facility: Teva Investigational Sites
city: Kempten
country: Germany
facility: Teva Investigational Sites
city: Kiel
country: Germany
facility: Teva Investigational Sites
city: Kleve
country: Germany
facility: Teva Investigational Sites
city: Krefeld
country: Germany
facility: Teva Investigational Sites
city: Köln
country: Germany
facility: Teva Investigational Sites
city: Königsbrück
country: Germany
facility: Teva Investigational Sites
city: Ladenburg
country: Germany
facility: Teva Investigational Sites
city: Landshut
country: Germany
facility: Teva Investigational Sites
city: Lappersdorg
country: Germany
facility: Teva Investigational Sites
city: Lauf
country: Germany
facility: Teva Investigational Sites
city: Leer
country: Germany
facility: Teva Investigational Sites
city: Leipzig
country: Germany
facility: Teva Investigational Sites
city: Leverkusen
country: Germany
facility: Teva Investigational Sites
city: Limburg
country: Germany
facility: Teva Investigational Sites
city: Lingen
country: Germany
facility: Teva Investigational Sites
city: Lohr
country: Germany
facility: Teva Investigational Sites
city: Ludwigshafen
country: Germany
facility: Teva Investigational Sites
city: Magdeburg
country: Germany
facility: Teva Investigational Sites
city: Mainz
country: Germany
facility: Teva Investigational Sites
city: Mannheim
country: Germany
facility: Teva Investigational Sites
city: Markkleeberg
country: Germany
facility: Teva Investigational Sites
city: Menden
country: Germany
facility: Teva Investigational Sites
city: Mittweida
country: Germany
facility: Teva Investigational Sites
city: Mönchengladbach
country: Germany
facility: Teva Investigational Sites
city: Mühlhausen
country: Germany
facility: Teva Investigational Sites
city: München
country: Germany
facility: Teva Investigational Sites
city: Naumburg
country: Germany
facility: Teva Investigational Sites
city: Neu-Ulm
country: Germany
facility: Teva Investigational Sites
city: Neuburg
country: Germany
facility: Teva Investigational Sites
city: Neunkirchen
country: Germany
facility: Teva Investigational Sites
city: Neupotz
country: Germany
facility: Teva Investigational Sites
city: Neusäß
country: Germany
facility: Teva Investigational Sites
city: Nürnberg
country: Germany
facility: Teva Investigational Sites
city: Oberhausen
country: Germany
facility: Teva Investigational Sites
city: Oldenburg
country: Germany
facility: Teva Investigational Sites
city: Osnabrück
country: Germany
facility: Teva Investigational Sites
city: Ostfildern
country: Germany
facility: Teva Investigational Sites
city: Pulheim
country: Germany
facility: Teva Investigational Sites
city: Ravensburg
country: Germany
facility: Teva Investigational Sites
city: Regensburg
country: Germany
facility: Teva Investigational Sites
city: Ribnitz-Damgarten
country: Germany
facility: Teva Investigational Sites
city: Rostock
country: Germany
facility: Teva Investigational Sites
city: Rotenburg
country: Germany
facility: Teva Investigational Sites
city: Saalouis
country: Germany
facility: Teva Investigational Sites
city: Sande
country: Germany
facility: Teva Investigational Sites
city: Schirgiswalkde-Kirschau
country: Germany
facility: Teva Investigational Sites
city: Schleiden
country: Germany
facility: Teva Investigational Sites
city: Schongau
country: Germany
facility: Teva Investigational Sites
city: Schwarzenbruck
country: Germany
facility: Teva Investigational Sites
city: Schweich
country: Germany
facility: Teva Investigational Sites
city: Schweinfurt
country: Germany
facility: Teva Investigational Sites
city: Schwerin
country: Germany
facility: Teva Investigational Sites
city: Schwetzingen
country: Germany
facility: Teva Investigational Sites
city: Seelow
country: Germany
facility: Teva Investigational Sites
city: Siegen
country: Germany
facility: Teva Investigational Sites
city: Sinsheim
country: Germany
facility: Teva Investigational Sites
city: Solingen
country: Germany
facility: Teva Investigational Sites
city: Sondershausen
country: Germany
facility: Teva Investigational Sites
city: Sprockhövel
country: Germany
facility: Teva Investigational Sites
city: Stade
country: Germany
facility: Teva Investigational Sites
city: Stralsund
country: Germany
facility: Teva Investigational Sites
city: Stuttgart
country: Germany
facility: Teva Investigational Sites
city: Treuenbrietzen
country: Germany
facility: Teva Investigational Sites
city: Troisdorg-Sieglar
country: Germany
facility: Teva Investigational Sites
city: Tübingen
country: Germany
facility: Teva Investigational Sites
city: Ulm
country: Germany
facility: Teva Investigational Sites
city: Varel
country: Germany
facility: Teva Investigational Sites
city: Vellmar
country: Germany
facility: Teva Investigational Sites
city: Weißenfels
country: Germany
facility: Teva Investigational Sites
city: Wismar
country: Germany
facility: Teva Investigational Sites
city: Wolfach
country: Germany
facility: Teva Investigational Sites
city: Wolfratshausen
country: Germany
facility: Teva Investigational Sites
city: Wuppertal
country: Germany
facility: Teva Investigational Sites
city: Zossen
country: Germany
facility: Teva Investigational Sites
city: Zwickau
country: Germany
facility: Teva Investigational Sites
Study officials:
affiliation: Paracelsus-Elena-Klinik Kassel
name: Medical Expert, MD
role: STUDY_DIRECTOR
References: