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)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00148486
First received: September 7, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: NS 2330
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined [ Time Frame: baseline and 14 Weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who were withdrawn from the study due to AEs [ Time Frame: baseline and 14 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in Part I, Part II, and Part III (separately) of the UPDRS [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Mean change in the Clinical Global Impressions (CGI)-Severity scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Mean change in the Modified Hoehn and Yahr Scale (MHYS) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Mean change in the Modified Schwab-England Disability Scale (MSED) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Mean change in the Auditory Verbal Learning Test (AVLT) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • mean score at Week 14 on the CGI-Improvement (which has no baseline rating) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of responder patients (20% and 30% improved on the total score of the UPDRS) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • vital signs (blood pressure and pulse rate) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • patients with abnormal laboratory test measurements [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • patients with abnormalities in electrocardiograms (ECGs) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale (ESS) (for daytime sleepiness) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Drug plasma concentration [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 261
Study Start Date: June 2003
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00148486

  Hide Study Locations
Locations
United States, Arizona
Pivotal Reaserch Centers
Peoria, Arizona, United States
Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
United States, California
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
United States, Connecticut
Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
UCONN Health Center
Farmington, Connecticut, United States
60 Temple St
New Haven, Connecticut, United States
United States, Florida
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
Renstar Medical Research
Ocala, Florida, United States
Boehringer Ingelheim Investigational Site
Ocala, Florida, United States
Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
CNS Clinical Trials
St. Piresburg, Florida, United States
University of Southern Florida
Tampa, Florida, United States
Movement Disorder Center
Tampa, Florida, United States
United States, Illinois
Department of Neurological Sciences
Chicago, Illinois, United States
United States, Indiana
Boehringer Ingelheim Investigational Site
Fort Wayne, Indiana, United States
Outpatient Clinical Research Facility
Indianapolis, Indiana, United States
United States, Kansas
Boehringer Ingelheim Investigational Site
Kansas City, Kansas, United States
United States, Louisiana
Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, Maine
Boehringer Ingelheim Investigational Site
Scarborough, Maine, United States
United States, Massachusetts
Future Care Studies
Springfield, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Michigan
Boehringer Ingelheim Investigational Site
Traverse City, Michigan, United States
United States, Minnesota
Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
University of Minesota
Minneapolis, Minnesota, United States
United States, Nebraska
Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
United States, New Jersey
Global Medical Institutes LLC
Toms River, New Jersey, United States
United States, New York
Upstate Clinical Resaerch LLC
Albany, New York, United States
Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, North Carolina
Boehringer Ingelheim Investigational Site
Wiston-Salem, North Carolina, United States
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States
Neurology Specialists Inc.
Dayton, Ohio, United States
United States, Oklahoma
St. John's Doctor Building
Tulsa, Oklahoma, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
United States, Texas
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
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, New Brunswick
Davidson Memory Clinic
Moncton, New Brunswick, Canada
Canada, Nova Scotia
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Centre For Movement Disorders
Markham, Ontario, Canada
Canada, Quebec
Clinical Research Consultant Group
Beaconsfield, Quebec, Canada
Canada, Saskatchewan
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Canada
Memory and Motor Skills Disorders Clinic
Quebec, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00148486     History of Changes
Other Study ID Numbers: 1198.100
Study First Received: September 7, 2005
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 20, 2014