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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)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NS 2330
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pivotal Reaserch Centers
  • Boehringer Ingelheim Investigational Site
  • PMDI
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • West Los Angeles VA Medical Center
  • Boehringer Ingelheim Investigational Site
  • UCONN Health Center
  • 60 Temple St
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • University of Florida
  • Sunrise Clinical Research
  • Department of Neurology
  • Miami Research Associates
  • Boehringer Ingelheim Investigational Site
  • Renstar Medical Research
  • Boehringer Ingelheim Investigational Site
  • CNS Clinical Trials
  • Movement Disorder Center
  • University of Southern Florida
  • Department of Neurological Sciences
  • Boehringer Ingelheim Investigational Site
  • Outpatient Clinical Research Facility
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Future Care Studies
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • University of Minesota
  • Boehringer Ingelheim Investigational Site
  • University of Nebraska Medical Center
  • Global Medical Institutes LLC
  • Upstate Clinical Resaerch LLC
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Ohio State University Medical Center
  • Neurology Specialists Inc.
  • St. John's Doctor Building
  • University of Pittsburgh Medical Center
  • The Methodist Hospital
  • Boehringer Ingelheim Investigational Site
  • North Texas Neurology Associates
  • University of Calgary
  • University of British Columbia
  • Davidson Memory Clinic
  • Boehringer Ingelheim Investigational Site
  • Centre For Movement Disorders
  • Clinical Research Consultant Group
  • Boehringer Ingelheim Investigational Site
  • Memory and Motor Skills Disorders Clinic

Outcomes

Primary Outcome Measures

Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined
Proportion of patients who were withdrawn from the study due to AEs

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2005
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00148486
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
261 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NS 2330
Primary Outcome Measure Information:
Title
Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined
Time Frame
baseline and 14 Weeks
Title
Proportion of patients who were withdrawn from the study due to AEs
Time Frame
baseline and 14 Weeks
Secondary Outcome Measure Information:
Title
Mean change in Part I, Part II, and Part III (separately) of the UPDRS
Time Frame
14 weeks
Title
Mean change in the Clinical Global Impressions (CGI)-Severity scale
Time Frame
14 weeks
Title
Mean change in the Modified Hoehn and Yahr Scale (MHYS)
Time Frame
14 weeks
Title
Mean change in the Modified Schwab-England Disability Scale (MSED)
Time Frame
14 weeks
Title
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
Title
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
Title
Mean change in the Auditory Verbal Learning Test (AVLT)
Time Frame
14 weeks
Title
mean score at Week 14 on the CGI-Improvement (which has no baseline rating)
Time Frame
14 weeks
Title
Proportion of responder patients (20% and 30% improved on the total score of the UPDRS)
Time Frame
14 weeks
Title
Incidence of adverse events
Time Frame
2 weeks
Title
vital signs (blood pressure and pulse rate)
Time Frame
20 weeks
Title
patients with abnormal laboratory test measurements
Time Frame
20 weeks
Title
patients with abnormalities in electrocardiograms (ECGs)
Time Frame
20 weeks
Title
Epworth Sleepiness Scale (ESS) (for daytime sleepiness)
Time Frame
20 weeks
Title
Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep
Time Frame
20 weeks
Title
Drug plasma concentration
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Pivotal Reaserch Centers
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
PMDI
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fresno
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Irvine
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Ocenside
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Oxnard
State/Province
California
Country
United States
Facility Name
West Los Angeles VA Medical Center
City
West Los Angeles
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Danbury
State/Province
Connecticut
Country
United States
Facility Name
UCONN Health Center
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
60 Temple St
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
University of Florida
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Sunrise Clinical Research
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Department of Neurology
City
Miami
State/Province
Florida
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Panama City
State/Province
Florida
Country
United States
Facility Name
CNS Clinical Trials
City
St. Piresburg
State/Province
Florida
Country
United States
Facility Name
Movement Disorder Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
University of Southern Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Department of Neurological Sciences
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Outpatient Clinical Research Facility
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Scarborough
State/Province
Maine
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Traverse City
State/Province
Michigan
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
University of Minesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Global Medical Institutes LLC
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
Upstate Clinical Resaerch LLC
City
Albany
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wiston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Neurology Specialists Inc.
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
St. John's Doctor Building
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
North Texas Neurology Associates
City
Wichita Falls
State/Province
Texas
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Davidson Memory Clinic
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Centre For Movement Disorders
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Clinical Research Consultant Group
City
Beaconsfield
State/Province
Quebec
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Memory and Motor Skills Disorders Clinic
City
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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)

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