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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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