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)
- Conditions
- Parkinson Disease
- Registration Number
- NCT00148486
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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to Week 14 in the score of the UPDRS, Parts I-III combined baseline and 14 Weeks Proportion of patients who were withdrawn from the study due to AEs baseline and 14 Weeks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 Outcome Measures
Name Time Method 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 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 Mean change in the Auditory Verbal Learning Test (AVLT) 14 weeks mean score at Week 14 on the CGI-Improvement (which has no baseline rating) 14 weeks patients with abnormal laboratory test measurements 20 weeks patients with abnormalities in electrocardiograms (ECGs) 20 weeks Epworth Sleepiness Scale (ESS) (for daytime sleepiness) 20 weeks Proportion of responder patients (20% and 30% improved on the total score of the UPDRS) 14 weeks vital signs (blood pressure and pulse rate) 20 weeks Mean change in the Modified Schwab-England Disability Scale (MSED) 14 weeks Mean change in Snaith-Hamilton Pleasure Scale (SHAPS) (including an additional analysis of the subset of patients with a pretreatment [screening] score of 3 or more) 14 weeks Incidence of adverse events 2 weeks Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep 20 weeks Drug plasma concentration 20 weeks
Trial Locations
- Locations (33)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Davidson Memory Clinic
🇨🇦Moncton, New Brunswick, Canada
Centre For Movement Disorders
🇨🇦Markham, Ontario, Canada
West Los Angeles VA Medical Center
🇺🇸West Los Angeles, California, United States
Sunrise Clinical Research
🇺🇸Hollywood, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
North Texas Neurology Associates
🇺🇸Wichita Falls, Texas, United States
PMDI
🇺🇸Fountain Valley, California, United States
CNS Clinical Trials
🇺🇸St. Piresburg, Florida, United States
Department of Neurological Sciences
🇺🇸Chicago, Illinois, United States
Future Care Studies
🇺🇸Springfield, Massachusetts, United States
Global Medical Institutes LLC
🇺🇸Toms River, New Jersey, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Upstate Clinical Resaerch LLC
🇺🇸Albany, New York, United States
St. John's Doctor Building
🇺🇸Tulsa, Oklahoma, United States
Neurology Specialists Inc.
🇺🇸Dayton, Ohio, United States
Memory and Motor Skills Disorders Clinic
🇨🇦Quebec, Canada
Pivotal Reaserch Centers
🇺🇸Peoria, Arizona, United States
UCONN Health Center
🇺🇸Farmington, Connecticut, United States
Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
60 Temple St
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainsville, Florida, United States
Department of Neurology
🇺🇸Miami, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Movement Disorder Center
🇺🇸Tampa, Florida, United States
University of Southern Florida
🇺🇸Tampa, Florida, United States
Outpatient Clinical Research Facility
🇺🇸Indianapolis, Indiana, United States
University of Minesota
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Clinical Research Consultant Group
🇨🇦Beaconsfield, Quebec, Canada