We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00148486
First Posted: September 8, 2005
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined [ Time Frame: baseline and 14 Weeks ]
  • Proportion of patients who were withdrawn from the study due to AEs [ Time Frame: baseline and 14 Weeks ]

Secondary Outcome Measures:
  • Mean change in Part I, Part II, and Part III (separately) of the UPDRS [ Time Frame: 14 weeks ]
  • Mean change in the Clinical Global Impressions (CGI)-Severity scale [ Time Frame: 14 weeks ]
  • Mean change in the Modified Hoehn and Yahr Scale (MHYS) [ Time Frame: 14 weeks ]
  • Mean change in the Modified Schwab-England Disability Scale (MSED) [ Time Frame: 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 ]
  • 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 ]
  • Mean change in the Auditory Verbal Learning Test (AVLT) [ Time Frame: 14 weeks ]
  • mean score at Week 14 on the CGI-Improvement (which has no baseline rating) [ Time Frame: 14 weeks ]
  • Proportion of responder patients (20% and 30% improved on the total score of the UPDRS) [ Time Frame: 14 weeks ]
  • Incidence of adverse events [ Time Frame: 2 weeks ]
  • vital signs (blood pressure and pulse rate) [ Time Frame: 20 weeks ]
  • patients with abnormal laboratory test measurements [ Time Frame: 20 weeks ]
  • patients with abnormalities in electrocardiograms (ECGs) [ Time Frame: 20 weeks ]
  • Epworth Sleepiness Scale (ESS) (for daytime sleepiness) [ Time Frame: 20 weeks ]
  • Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep [ Time Frame: 20 weeks ]
  • Drug plasma concentration [ Time Frame: 20 weeks ]

Estimated Enrollment: 261
Study Start Date: June 2003
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148486


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

ClinicalTrials.gov Identifier: NCT00148486     History of Changes
Other Study ID Numbers: 1198.100
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: October 29, 2013
Last Verified: October 2013

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