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

Phase 4

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: rasagiline mesylate; Drug: Rasagiline mesylate plus Mirapex; Drug: Rasagiline mesylate with Levodopa; Drug: Rasagiline mesylate with Requip

• Registration Number: NCT00399477
• Lead Sponsor: Teva Neuroscience, Inc.

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

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-10
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rasagiline mesylate plus adjunct therapy	Rasagiline mesylate with Levodopa	Rasagiline mesylate with one of three adjunct therapies
Rasagiline mesylate	rasagiline mesylate	-
Rasagiline mesylate plus adjunct therapy	Rasagiline mesylate plus Mirapex	Rasagiline mesylate with one of three adjunct therapies
Rasagiline mesylate plus adjunct therapy	Rasagiline mesylate with Requip	Rasagiline mesylate with one of three adjunct therapies

Primary Outcome Measures

Name	Time	Method
To identify the earliest scheduled visit of symptomatic effect	8 months

Secondary Outcome Measures

Name	Time	Method
To characterize the effectiveness of Azilect in a usual community neurological	8 months