Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations

A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: rasagiline mesylate; Drug: 1.0 mg rasagiline mesylate; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush - Presbyterian St. Luke's Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia - Presbyterian Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism.

Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the OFF state.

Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose.

Selegiline must be discontinued for at least 90 days prior to baseline.

Subject must be age 30 or older.

Subjects must be willing and able to give informed consent.

Exclusion Criteria:

Subjects with 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, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest x-ray, or ECG for Parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)] within the 12 months preceding the Baseline visit.

Subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. No programming changes are permitted in subjects who have undergone DBS.

Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Comparator	Other: Placebo; oral placebo once daily
Experimental: Experimental 1; 0.5 mg rasagiline mesylate oral once daily	Drug: rasagiline mesylate; 0.5 mg rasagiline mesylate oral once daily
Experimental: Experimental 2; 1.0 mg rasagiline mesylate oral once daily	Drug: 1.0 mg rasagiline mesylate; 1.0 mg rasagiline mesylate oral once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the mean total daily "OFF" time	26 weeks

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Principal Investigator: Ira Shoulson, MD, The Parkinson Study Group

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (Actual): January 1, 2003
• Study Completion (Actual): January 1, 2003

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): March 9, 2010
• Last Update Submitted That Met QC Criteria: March 8, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: TV-1012/133