Status:
COMPLETED
A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability of NS 2330 in th...
Eligibility Criteria
Inclusion
- Parkinson's disease for \<5 years, non-demented, no or \<6 months of levodopa and none during trial. Off levodopa, DA agonists, and psychotropics for 30 days before screening. Amantadine, anticholinergics allowed if at stable dosage. Hoehn \& Yahr stage I-III. Depression allowed, but no other chronic disease that is unstable or might interfere with ability to participate.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00148486
Start Date
June 1 2003
Last Update
October 29 2013
Active Locations (55)
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1
Pivotal Reaserch Centers
Peoria, Arizona, United States
2
Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
3
PMDI
Fountain Valley, California, United States
4
Boehringer Ingelheim Investigational Site
Fresno, California, United States