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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399477
• Other study ID #: TVP-1012/PM101
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2006
• Last updated: April 8, 2011
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• rasagiline mesylate
Azilect®
• Rasagiline mesylate plus Mirapex
Mirapex, Azilect®
• Rasagiline mesylate with Levodopa
Azilect®, Levodopa
• Rasagiline mesylate with Requip
Azilect®, Requip

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Neuroscience, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the earliest scheduled visit of symptomatic effect		8 months	No
Secondary	To characterize the effectiveness of Azilect in a usual community neurological		8 months	No