Azilect® In Wearing-Off (AIWO) | NCT02384512

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Mar 4, 2015

First Submission Date that Met QC Criteria

Mar 9, 2015

First Posted Date

Mar 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

Name	Class
Anfomed GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

261Actual

Name	Type	Description	Arm Group Labels	Other Names
Azilect®	Drug	AZILECT® 1mg Tablets		Rasagiline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
WHO-5	Alterations of patient's Quality of life (patient questionnaire)	12 weeks
GI-I	Self-Assessment of global improvement (patient questionnaire)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants will be patients with Parkinson's disease in Germany

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Expert, MD	Paracelsus Elena Klinik	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Sites		Aalen			Germany
Teva Investigational Sites

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases