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)

NCT ID: NCT00148486

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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NS 2330

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Pivotal Reaserch Centers

Peoria, Arizona, United States

Site Status

Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Site Status

PMDI

Fountain Valley, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Fresno, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Irvine, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Ocenside, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Oxnard, California, United States

Site Status

West Los Angeles VA Medical Center

West Los Angeles, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Site Status

UCONN Health Center

Farmington, Connecticut, United States

Site Status

60 Temple St

New Haven, Connecticut, United States

Site Status

Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Site Status

University of Florida

Gainsville, Florida, United States

Site Status

Sunrise Clinical Research

Hollywood, Florida, United States

Site Status

Department of Neurology

Miami, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Ocala, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

CNS Clinical Trials

Saint Piresburg, Florida, United States

Site Status

Movement Disorder Center

Tampa, Florida, United States

Site Status

University of Southern Florida

Tampa, Florida, United States

Site Status

Department of Neurological Sciences

Chicago, Illinois, United States

Site Status

Boehringer Ingelheim Investigational Site

Fort Wayne, Indiana, United States

Site Status

Outpatient Clinical Research Facility

Indianapolis, Indiana, United States

Site Status

Boehringer Ingelheim Investigational Site

Kansas City, Kansas, United States

Site Status

Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Site Status

Boehringer Ingelheim Investigational Site

Scarborough, Maine, United States

Site Status

Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Site Status

Future Care Studies

Springfield, Massachusetts, United States

Site Status

Boehringer Ingelheim Investigational Site

Traverse City, Michigan, United States

Site Status

Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Site Status

University of Minesota

Minneapolis, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Global Medical Institutes LLC

Toms River, New Jersey, United States

Site Status

Upstate Clinical Resaerch LLC

Albany, New York, United States

Site Status

Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

Boehringer Ingelheim Investigational Site

Wiston-Salem, North Carolina, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Neurology Specialists Inc.

Dayton, Ohio, United States

Site Status

St. John's Doctor Building

Tulsa, Oklahoma, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

North Texas Neurology Associates

Wichita Falls, Texas, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Davidson Memory Clinic

Moncton, New Brunswick, Canada

Site Status

Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Centre For Movement Disorders

Markham, Ontario, Canada

Site Status

Clinical Research Consultant Group

Beaconsfield, Quebec, Canada

Site Status

Memory and Motor Skills Disorders Clinic

Québec, Quebec, Canada

Site Status

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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1198.100

Identifier Type: -

Identifier Source: org_study_id