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)
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)
1 other identifier
interventional
261
2 countries
55
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 these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
55 active sites
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
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedOctober 29, 2013
October 1, 2013
1.8 years
September 7, 2005
October 28, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined
baseline and 14 Weeks
Proportion of patients who were withdrawn from the study due to AEs
baseline and 14 Weeks
Secondary Outcomes (16)
Mean change in Part I, Part II, and Part III (separately) of the UPDRS
14 weeks
Mean change in the Clinical Global Impressions (CGI)-Severity scale
14 weeks
Mean change in the Modified Hoehn and Yahr Scale (MHYS)
14 weeks
Mean change in the Modified Schwab-England Disability Scale (MSED)
14 weeks
Mean change in the Hamilton Depression Scale (HAMD) (GRID version) (including an additional analysis of the subset of patients with a pretreatment [screening] score of 14 or more)
14 weeks
- +11 more secondary outcomes
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (55)
Pivotal Reaserch Centers
Peoria, Arizona, United States
Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
PMDI
Fountain Valley, California, United States
Boehringer Ingelheim Investigational Site
Fresno, California, United States
Boehringer Ingelheim Investigational Site
Irvine, California, United States
Boehringer Ingelheim Investigational Site
Ocenside, California, United States
Boehringer Ingelheim Investigational Site
Oxnard, California, United States
West Los Angeles VA Medical Center
West Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
UCONN Health Center
Farmington, Connecticut, United States
60 Temple St
New Haven, Connecticut, United States
Boehringer Ingelheim Investigational Site
Boca Raton, Florida, United States
Boehringer Ingelheim Investigational Site
Bradenton, Florida, United States
University of Florida
Gainsville, Florida, United States
Sunrise Clinical Research
Hollywood, Florida, United States
Department of Neurology
Miami, Florida, United States
Miami Research Associates
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
CNS Clinical Trials
Saint Piresburg, Florida, United States
Movement Disorder Center
Tampa, Florida, United States
University of Southern Florida
Tampa, Florida, United States
Department of Neurological Sciences
Chicago, Illinois, United States
Boehringer Ingelheim Investigational Site
Fort Wayne, Indiana, United States
Outpatient Clinical Research Facility
Indianapolis, Indiana, United States
Boehringer Ingelheim Investigational Site
Kansas City, Kansas, United States
Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
Boehringer Ingelheim Investigational Site
Scarborough, Maine, United States
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
Future Care Studies
Springfield, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Traverse City, Michigan, United States
Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
University of Minesota
Minneapolis, Minnesota, United States
Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Global Medical Institutes LLC
Toms River, New Jersey, United States
Upstate Clinical Resaerch LLC
Albany, New York, United States
Boehringer Ingelheim Investigational Site
New York, New York, United States
Boehringer Ingelheim Investigational Site
Wiston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Neurology Specialists Inc.
Dayton, Ohio, United States
St. John's Doctor Building
Tulsa, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The Methodist Hospital
Houston, Texas, United States
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
North Texas Neurology Associates
Wichita Falls, Texas, United States
University of Calgary
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Davidson Memory Clinic
Moncton, New Brunswick, Canada
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Centre For Movement Disorders
Markham, Ontario, Canada
Clinical Research Consultant Group
Beaconsfield, Quebec, Canada
Memory and Motor Skills Disorders Clinic
Québec, Quebec, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
June 1, 2003
Primary Completion
March 1, 2005
Last Updated
October 29, 2013
Record last verified: 2013-10