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
ClinicalTrials.gov Identifier:
NCT00148486
First received: September 7, 2005
Last updated: October 28, 2013
Last verified: October 2013
  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: 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 ] [ Designated as safety issue: No ]
  • Proportion of patients who were withdrawn from the study due to AEs [ Time Frame: baseline and 14 Weeks ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 261
Study Start Date: June 2003
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  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
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, see Learn About Clinical Studies.

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

  Show 55 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  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: October 28, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014