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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399477

Enrollment

200

Registered

2006-11-14

Start date

2006-10-31

Completion date

2007-07-31

Last updated

2011-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DRUGrasagiline mesylate

Azilect®

DRUGRasagiline mesylate plus Mirapex

Mirapex, Azilect®

DRUGRasagiline mesylate with Levodopa

Azilect®, Levodopa

DRUGRasagiline mesylate with Requip

Azilect®, Requip

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To identify the earliest scheduled visit of symptomatic effect	8 months

Secondary

Measure	Time frame
To characterize the effectiveness of Azilect in a usual community neurological	8 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026