Parkinson's DiseaseAIWONCT02384512

Azilect® In Wearing-Off (AIWO)

An observational study of Parkinson's Disease, run by Teva Pharma GmbH at 140 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Azilect®
Type of treatment: Pill or oral medicine
How many people: 261 participants
Where: 140 sitesGermany
Study dates: Jan 2014to Jan 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants will be patients with Parkinson's disease in Germany

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

140 sites in 1 country.

City, postcode or hospital

140 sites in 1 country

Germany140 sites

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

Other trials in Germany

About this study

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)

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.

Read the 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).

Conditions: Parkinson's Disease
Being tested: Azilect®
Keywords: Parkinson's disease, akinesia, Azilect®, Rasagiline, Combination therapy with L-dopa, Wearing-off Questionnaire-32, Quality of life, Daily practice
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azilect®Drug
Also called Rasagiline
AZILECT® 1mg Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Wearing-off Questionnaire-32 (WOQ-32)
Alterations of 32 different wearing-off symptoms (Patient questionnaire)
Measured: 12 weeks

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jan 2015

First posted10 Mar 2015 (estimated)
Study startJan 2014
Primary completionDec 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02384512
Sponsor's protocol ID: TVP1012-CNS-40090
Acronym: AIWO
Status last verified: Apr 2023
First submitted: 4 Mar 2015
Last updated: 12 Apr 2023
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02384512
Acronym / sponsor ID: AIWO / TVP1012-CNS-40090
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
Study type: Observational
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: Teva Pharma GmbHIndustry (pharma, biotech, devices)
Collaborators: Anfomed GmbH
Study start: Jan 2014
Primary completion: Dec 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 10 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants will be patients with Parkinson's disease in Germany

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azilect®Also: RasagilineAZILECT® 1mg Tablets	Drug	–

Primary outcome

Wearing-off Questionnaire-32 (WOQ-32)
Time frame: 12 weeks
Alterations of 32 different wearing-off symptoms (Patient questionnaire)

5 secondary outcomes

WHO-5
Time frame: 12 weeks
GI-I
Time frame: 12 weeks
Columbia University Rating Scale (CURS)
Time frame: 12 weeks
Clinical global impression improvement (CGI-I)
Time frame: 12 weeks
Percentage of participants with adverse events
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.

Related trials for Parkinson's Disease

Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Expert, MD study director

Paracelsus Elena Klinik

140 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Teva Pharma GmbH at 140 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wearing-off Questionnaire-32 (WOQ-32) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.