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

NCT ID: NCT00399477

Last Updated: 2011-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rasagiline mesylate

Group Type ACTIVE_COMPARATOR

rasagiline mesylate

Intervention Type DRUG

Azilect®

Rasagiline mesylate plus adjunct therapy

Rasagiline mesylate with one of three adjunct therapies

Group Type EXPERIMENTAL

Rasagiline mesylate plus Mirapex

Intervention Type DRUG

Mirapex, Azilect®

Rasagiline mesylate with Levodopa

Intervention Type DRUG

Azilect®, Levodopa

Rasagiline mesylate with Requip

Intervention Type DRUG

Azilect®, Requip

Interventions

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rasagiline mesylate

Azilect®

Intervention Type DRUG

Rasagiline mesylate plus Mirapex

Mirapex, Azilect®

Intervention Type DRUG

Rasagiline mesylate with Levodopa

Azilect®, Levodopa

Intervention Type DRUG

Rasagiline mesylate with Requip

Azilect®, Requip

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Requiring therapy for PD symptom control

* Azilect monotherapy.
* Azilect as adjunct therapy..

Exclusion Criteria

1. Patients previously exposed to Azilect
2. Patients with pheochromocytoma
3. Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Neuroscience

Principal Investigators

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MerriKay Oleen-Burkey, PhD

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

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TVP-1012/PM101

Identifier Type: -

Identifier Source: org_study_id

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