Azilect® In Wearing-Off (AIWO)

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02384512

Acronym

AIWO

Enrollment

261

Registered

2015-03-10

Start date

2014-01-31

Completion date

2015-01-31

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

DRUGAzilect®

AZILECT® 1mg Tablets

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026