Status:
COMPLETED
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
Lead Sponsor:
GlaxoSmithKline
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's disease
- Modified Hoehn and Yahr Scale Stages II - IV
- Stable dose of L-dopa for at least 4 weeks prior to screening.
- Lack of control with L-dopa therapy.
- Women of child-bearing potential must use a clinically accepted form of birth control.
Exclusion
- Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.
- Any abnormality, at screening, that is considered clinically relevant by the Investigator.
- Dementia
- Use of dopamine agonists within 4 weeks of screening visit.
- Participation in other investigational drug studies.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
393 Patients enrolled
Trial Details
Trial ID
NCT00381472
Start Date
June 1 2003
End Date
December 1 2004
Last Update
March 23 2017
Active Locations (76)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294-2041
2
GSK Investigational Site
Northridge, California, United States, 91325
3
GSK Investigational Site
San Francisco, California, United States, 94109
4
GSK Investigational Site
Englewood, Colorado, United States, 80110