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)

October 28, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

261

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Memory and Motor Skills Disorders Clinic
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Davidson Memory Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Boehringer Ingelheim Investigational Site
    • Ontario
      • Markham, Ontario, Canada
        • Centre for Movement Disorders
    • Quebec
      • Beaconsfield, Quebec, Canada
        • Clinical Research Consultant Group
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Peoria, Arizona, United States
        • Pivotal Reaserch Centers
      • Tucson, Arizona, United States
        • Boehringer Ingelheim Investigational Site
    • California
      • Fountain Valley, California, United States
        • PMDI
      • 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
        • Boehringer Ingelheim Investigational Site
      • West Los Angeles, California, United States
        • West Los Angeles VA Medical Center
    • Connecticut
      • Danbury, Connecticut, United States
        • Boehringer Ingelheim Investigational Site
      • Farmington, Connecticut, United States
        • UConn Health Center
      • New Haven, Connecticut, United States
        • 60 Temple St
    • Florida
      • Boca Raton, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Bradenton, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Gainsville, Florida, United States
        • University of Florida
      • Hollywood, Florida, United States
        • Sunrise Clinical Research
      • Miami, Florida, United States
        • Miami Research Associates
      • Miami, Florida, United States
        • Department of Neurology
      • Ocala, Florida, United States
        • Renstar Medical Research
      • Ocala, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Panama City, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • St. Piresburg, Florida, United States
        • CNS Clinical Trials
      • Tampa, Florida, United States
        • Movement Disorder Center
      • Tampa, Florida, United States
        • University of Southern Florida
    • Illinois
      • Chicago, Illinois, United States
        • Department of Neurological Sciences
    • Indiana
      • Fort Wayne, Indiana, United States
        • Boehringer Ingelheim Investigational Site
      • Indianapolis, Indiana, United States
        • Outpatient Clinical Research Facility
    • Kansas
      • Kansas City, Kansas, United States
        • Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Boehringer Ingelheim Investigational Site
    • Maine
      • Scarborough, Maine, United States
        • Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, United States
        • Future Care Studies
    • Michigan
      • Traverse City, Michigan, United States
        • Boehringer Ingelheim Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Boehringer Ingelheim Investigational Site
      • Minneapolis, Minnesota, United States
        • University of Minesota
    • Nebraska
      • Omaha, Nebraska, United States
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States
        • Boehringer Ingelheim Investigational Site
    • New Jersey
      • Toms River, New Jersey, United States
        • Global Medical Institutes LLC
    • New York
      • Albany, New York, United States
        • Upstate Clinical Resaerch LLC
      • New York, New York, United States
        • Boehringer Ingelheim Investigational Site
    • North Carolina
      • Wiston-Salem, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • Ohio State University Medical Center
      • Dayton, Ohio, United States
        • Neurology Specialists Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • St. John's Doctor Building
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States
        • The Methodist Hospital
      • San Antonio, Texas, United States
        • Boehringer Ingelheim Investigational Site
      • Wichita Falls, Texas, United States
        • North Texas Neurology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined
Time Frame: baseline and 14 Weeks
baseline and 14 Weeks
Proportion of patients who were withdrawn from the study due to AEs
Time Frame: baseline and 14 Weeks
baseline and 14 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1198.100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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