NCT00203034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2000

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

2.7 years

First QC Date

September 13, 2005

Last Update Submit

March 8, 2010

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the mean total daily "OFF" time

    26 weeks

Study Arms (3)

Experimental 1

EXPERIMENTAL

0.5 mg rasagiline mesylate oral once daily

Drug: rasagiline mesylate

Experimental 2

EXPERIMENTAL

1.0 mg rasagiline mesylate oral once daily

Drug: 1.0 mg rasagiline mesylate

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Other: Placebo

Interventions

rasagiline mesylateDRUG

0.5 mg rasagiline mesylate oral once daily

Experimental 1
1.0 mg rasagiline mesylateDRUG

1.0 mg rasagiline mesylate oral once daily

Experimental 2
PlaceboOTHER

oral placebo once daily

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rush - Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Columbia - Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ira Shoulson, MD

    The Parkinson Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 1, 2000

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations

US(4)