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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

September 13, 2005
March 8, 2010
May 2000
January 2003   (final data collection date for primary outcome measure)
Change from baseline in the mean total daily "OFF" time [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from baseline in the mean total daily “OFF” time
Complete list of historical versions of study NCT00203034 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: rasagiline mesylate
    0.5 mg rasagiline mesylate oral once daily
  • Drug: 1.0 mg rasagiline mesylate
    1.0 mg rasagiline mesylate oral once daily
  • Other: Placebo
    oral placebo once daily
  • Experimental: Experimental 1
    0.5 mg rasagiline mesylate oral once daily
    Intervention: Drug: rasagiline mesylate
  • Experimental: Experimental 2
    1.0 mg rasagiline mesylate oral once daily
    Intervention: Drug: 1.0 mg rasagiline mesylate
  • Placebo Comparator: Placebo
    Placebo Comparator
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
472
January 2003
January 2003   (final data collection date for primary outcome measure)

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.

Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00203034
TV-1012/133
Yes
Siyu Liu, MD, PhD, VP I R&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D
Teva Pharmaceutical Industries
Not Provided
Principal Investigator: Ira Shoulson, MD The Parkinson Study Group
Teva Pharmaceutical Industries
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP