Rasagiline in Advanced Parkinson’s Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.

Overview

Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.

Full Title of Study: “A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson’s Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2006

Interventions

  • Drug: rasagiline mesylate
    • 0.5 rasagiline mesylate
  • Drug: rasagiline mesylate 1.0 mg
    • 1.0 mg rasagiline mesylate

Arms, Groups and Cohorts

  • Experimental: Experimental 1
    • 0.5 mg rasagiline mesylate oral once daily
  • Experimental: Expermental 2
    • 1.0 mg rasagiline mesylate oral once daily

Clinical Trial Outcome Measures

Primary Measures

  • long-term safety and tolerability of rasagiline
    • Time Frame: 6 months
    • To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy.

Secondary Measures

  • long- term clinical effect of rasagiline
    • Time Frame: 6 months
    • To assess the long- term clinical effect of rasagiline on the course of the disease.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol. – Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0. – Patients must be willing and able to give informed consent. Exclusion Criteria:

  • Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133. – Premature discontinuation from study TVP 1012/133 for any reason. – A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary hepatic, renal, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Siyu Liu, MD, PhD, VP IR&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D
  • Overall Official(s)
    • Phyllis Salzman, Ph.D., Study Director, Teva Neuroscience, Inc.

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