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OpenTrials
Completed

NCT Number: NCT00203177

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHUM-Hotel-Dieu, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rasagiline mesylate

Drug

0.5 rasagiline mesylate

rasagiline mesylate 1.0 mg

Drug

1.0 mg rasagiline mesylate

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2001
Primary completion
2006
First posted
Sep 20, 2005
Registry last updated
Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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