Text Size

Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203060
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose

Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.


Condition Intervention Phase
Parkinson's Disease
 Drug: Rasagiline Mesylate
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks. [ Time Frame: 58 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 404
Study Start Date: July 1997
Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Rasagiline treatment
 Drug: Rasagiline Mesylate
tablet, 1 or 2 mg, daily, 58 weeks
Placebo Comparator: B
placebo arm
 Drug: placebo
tablet, once daily, 58 weeks

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Subjects must be age 35 years or older.

Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.

Exclusion Criteria:

Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203060

Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: Sheila Oren, MD Teva Pharmaceutical Industries
  More Information

Additional Information:
For mor information about Parkinson's Disease  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: J. Michael Nicholas, Ph.D. Sr. Director, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00203060     History of Changes
Other Study ID Numbers: TVP-1012/232
Study First Received: September 13, 2005
Last Updated: April 8, 2011
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 May 23, 2013