Azilect® In Wearing-Off (AIWO)

Teva Pharmaceuticals

Status: Completed

Conditions: Parkinson's Disease

Treatments: Drug: Azilect®

Study type: Observational

Funder types: Industry

Identifiers

NCT02384512

TVP1012-CNS-40090

Details and patient eligibility

About

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.

Full 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).

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.