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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)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00148486
First received: September 7, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
 Drug: NS 2330
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 14-Week Placebo-Controlled Dose-Response Efficacy and Safety in Early PD (SCEPTRE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint was the mean change in score of the UPDRS, Parts I-III combined, from Baseline to Week 14.

Secondary Outcome Measures:
  • Secondary efficacy measures were mean change in: Part I, Part II, and Part III (separately) of the UPDRS, the CGI-Severity, the Modified Hoehn and Yahr Scale, the Modified Schwab-England Disability Scale (MSED) and the HAMD.

Estimated Enrollment: 244
Study Start Date: June 2003
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148486

  Show 55 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00148486     History of Changes
Other Study ID Numbers: 1198.100
Study First Received: September 7, 2005
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 22, 2013