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

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: rasagiline mesylate; Drug: Rasagiline mesylate with Levodopa; Drug: Rasagiline mesylate plus Mirapex; Drug: Rasagiline mesylate with Requip

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399477

TVP-1012/PM101

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 30+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Rasagiline mesylate

Active Comparator group

Treatment:

Drug: rasagiline mesylate

Rasagiline mesylate plus adjunct therapy

Experimental group

Description:

Rasagiline mesylate with one of three adjunct therapies

Treatment:

Drug: Rasagiline mesylate with Levodopa

Drug: Rasagiline mesylate with Requip

Drug: Rasagiline mesylate plus Mirapex