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Parkinson DiseasePhase 2NCT00148486

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)

A Phase 2 study testing NS 2330 in people with Parkinson Disease, run by Boehringer Ingelheim at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
NS 2330
How many people
261 participants
Where
55 sitesin 2 countries
Study dates
Jun 2003to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States47 sites

  • Upstate Clinical Resaerch LLC

    Albany, New York

  • Boehringer Ingelheim Investigational Site

    Boca Raton, Florida

  • Boehringer Ingelheim Investigational Site

    Bradenton, Florida

  • Department of Neurological Sciences

    Chicago, Illinois

  • Ohio State University Medical Center

    Columbus, Ohio

  • Boehringer Ingelheim Investigational Site

    Danbury, Connecticut

  • Neurology Specialists Inc.

    Dayton, Ohio

  • UCONN Health Center

    Farmington, Connecticut

  • Boehringer Ingelheim Investigational Site

    Fort Wayne, Indiana

  • PMDI

    Fountain Valley, California

  • Boehringer Ingelheim Investigational Site

    Fresno, California

  • University of Florida

    Gainsville, Florida

  • Sunrise Clinical Research

    Hollywood, Florida

  • The Methodist Hospital

    Houston, Texas

  • Outpatient Clinical Research Facility

    Indianapolis, Indiana

  • Boehringer Ingelheim Investigational Site

    Irvine, California

  • Boehringer Ingelheim Investigational Site

    Kansas City, Kansas

  • Department of Neurology

    Miami, Florida

  • Miami Research Associates

    Miami, Florida

  • Boehringer Ingelheim Investigational Site

    Minneapolis, Minnesota

  • University of Minesota

    Minneapolis, Minnesota

  • 60 Temple St

    New Haven, Connecticut

  • Boehringer Ingelheim Investigational Site

    New York, New York

  • Boehringer Ingelheim Investigational Site

    Ocala, Florida

  • Renstar Medical Research

    Ocala, Florida

  • Boehringer Ingelheim Investigational Site

    Ocenside, California

  • Boehringer Ingelheim Investigational Site

    Omaha, Nebraska

  • University of Nebraska Medical Center

    Omaha, Nebraska

  • Boehringer Ingelheim Investigational Site

    Oxnard, California

  • Boehringer Ingelheim Investigational Site

    Panama City, Florida

  • Pivotal Reaserch Centers

    Peoria, Arizona

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania

  • CNS Clinical Trials

    Saint Piresburg, Florida

  • Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • Boehringer Ingelheim Investigational Site

    Scarborough, Maine

  • Boehringer Ingelheim Investigational Site

    Shreveport, Louisiana

  • Boehringer Ingelheim Investigational Site

    Springfield, Massachusetts

  • Future Care Studies

    Springfield, Massachusetts

  • Movement Disorder Center

    Tampa, Florida

  • University of Southern Florida

    Tampa, Florida

  • Global Medical Institutes LLC

    Toms River, New Jersey

  • Boehringer Ingelheim Investigational Site

    Traverse City, Michigan

  • Boehringer Ingelheim Investigational Site

    Tucson, Arizona

  • St. John's Doctor Building

    Tulsa, Oklahoma

  • West Los Angeles VA Medical Center

    West Los Angeles, California

  • North Texas Neurology Associates

    Wichita Falls, Texas

  • Boehringer Ingelheim Investigational Site

    Wiston-Salem, North Carolina

Other trials in United States

Canada8 sites

  • Clinical Research Consultant Group

    Beaconsfield, Quebec

  • University of Calgary

    Calgary, Alberta

  • Boehringer Ingelheim Investigational Site

    Halifax, Nova Scotia

  • Centre For Movement Disorders

    Markham, Ontario

  • Davidson Memory Clinic

    Moncton, New Brunswick

  • Memory and Motor Skills Disorders Clinic

    Québec, Quebec

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan

  • University of British Columbia

    Vancouver, British Columbia

Other trials in Canada

About this study

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)

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.

Being tested
NS 2330
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NS 2330Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined

    Measured: baseline and 14 Weeks

  2. Proportion of patients who were withdrawn from the study due to AEs

    Measured: baseline and 14 Weeks

Secondary outcomes (16)

  1. Mean change in Part I, Part II, and Part III (separately) of the UPDRS

    Measured: 14 weeks

  2. Mean change in the Clinical Global Impressions (CGI)-Severity scale

    Measured: 14 weeks

  3. Mean change in the Modified Hoehn and Yahr Scale (MHYS)

    Measured: 14 weeks

  4. Mean change in the Modified Schwab-England Disability Scale (MSED)

    Measured: 14 weeks

  5. 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)

    Measured: 14 weeks

  6. 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)

    Measured: 14 weeks

  7. Mean change in the Auditory Verbal Learning Test (AVLT)

    Measured: 14 weeks

  8. mean score at Week 14 on the CGI-Improvement (which has no baseline rating)

    Measured: 14 weeks

  9. Proportion of responder patients (20% and 30% improved on the total score of the UPDRS)

    Measured: 14 weeks

  10. Incidence of adverse events

    Measured: 2 weeks

  11. vital signs (blood pressure and pulse rate)

    Measured: 20 weeks

  12. patients with abnormal laboratory test measurements

    Measured: 20 weeks

  13. patients with abnormalities in electrocardiograms (ECGs)

    Measured: 20 weeks

  14. Epworth Sleepiness Scale (ESS) (for daytime sleepiness)

    Measured: 20 weeks

  15. Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep

    Measured: 20 weeks

  16. Drug plasma concentration

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
261 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00148486
Sponsor's protocol ID
1198.100
Status last verified
Oct 2013
First submitted
7 Sep 2005
Last updated
29 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NS 2330 in people with Parkinson Disease, run by Boehringer Ingelheim at 55 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined (time frame: baseline and 14 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00148486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.

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