A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

November 10, 2006

Last Updated Date

April 3, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To identify the earliest scheduled visit at which the symptomatic effect of
Azilect as initial monotherapy and as adjunct therapy can be demonstrated

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00399477 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To characterize the effectiveness of Azilect in a usual community neurological
practice by assessing investigator and patient-rated satisfaction and ease-of-use.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

Official Title ^ICMJE

Open-Label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)

Brief Summary

Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:

Group 1 Patients using Azilect and no other therapy.
Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.

Detailed Description

Open-label, multicentered Two hundred-fifty (250) enrolled patients will be stratified within each center by absence/presence of concomitant dopaminergic therapy

Azilect as monotherapy: Patients not currently receiving LD/CD or a dopamine agonist; Azilect as first line dopaminergic PD treatment
Azilect as adjunct therapy: Patients already receiving LD/CD and/or dopamine agonist
Approx. 1:1 ratio of mono- to adjunct therapy, for the study overall. Visits at Screening/Baseline, Weeks 1, 2, 4, and 12. Telephone contact at Week 8.

PD symptom scales, satisfaction/ease-of-use ratings, global evaluations and safety assessments to be completed by investigator and/or patient at baseline and at specified visits during the study.

For patients receiving Azilect as adjunct therapy, the use and dose changes of LD/CD and /or dopamine agonists will be recorded in detail.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Azilect (rasagiline mesylate)
Drug: Mirapex
Drug: Levodopa
Drug: Requip

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.
Requiring therapy for PD symptom control
- Azilect monotherapy.
- Azilect as adjunct therapy..

Exclusion Criteria:

Patients previously exposed to Azilect
Patients with pheochromocytoma
Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00399477

Responsible Party

Study ID Numbers ^ICMJE

TVP-1012/PM101

Study Sponsor ^ICMJE

Teva Pharmaceutical Industries

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

MerriKay Oleen-Burkey, PhD

Teva Neuroscience, Inc.

Information Provided By

Teva Pharmaceutical Industries

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP