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.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00148486

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 II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Tesofensine NS 2330

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	14-Week Placebo-Controlled Dose-Response Efficacy and Safety in Early PD (SCEPTRE)

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

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

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009