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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203034
First received: September 13, 2005
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Drug: rasagiline mesylate
Drug: 1.0 mg rasagiline mesylate
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change from baseline in the mean total daily "OFF" time [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 472
Study Start Date: May 2000
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Placebo Comparator
Other: Placebo
oral placebo once daily

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203034

Locations
United States, Illinois
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Columbia - Presbyterian Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Ira Shoulson, MD The Parkinson Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: Siyu Liu, MD, PhD, VP I R&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D
ClinicalTrials.gov Identifier: NCT00203034     History of Changes
Other Study ID Numbers: TV-1012/133
Study First Received: September 13, 2005
Last Updated: March 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Rasagiline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014