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)

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: March 2005

Interventions

  • Drug: NS 2330

Clinical Trial Outcome Measures

Primary 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  • Proportion of patients who were withdrawn from the study due to AEs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 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Overall Official(s)
    • Boehringer Ingelheim Study Coordinator, Study Chair, Boehringer Ingelheim

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