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

September 7, 2005
October 28, 2013
June 2003
March 2005   (final data collection date for 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 ] [ 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  • Proportion of patients who were withdrawn from the study due to AEs [ Time Frame: baseline and 14 Weeks ] [ Designated as safety issue: No ]
The primary endpoint was the mean change in score of the UPDRS, Parts I-III combined, from Baseline to Week 14.
Complete list of historical versions of study NCT00148486 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
Not Provided
Not Provided
 
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson Disease
Drug: NS 2330
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
Not Provided
March 2005   (final data collection date for primary outcome measure)

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.

Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00148486
1198.100
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP