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Trial · Interventional

CompletedPhase 2Registry data

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)

NCTNCT00148486 (opens ClinicalTrials.gov in a new tab)Other id1198.100
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Overview

Status
Completed
Phase
Phase 2
Enrollment
261 participants
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
Jun 2003
Primary completion
Mar 2005
Completion
Not stated
First posted
8 Sept 2005 (estimated)
Last update posted
29 Oct 2013 (estimated)
Conditions
Parkinson Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2003200420052006
  1. Ph 2

    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)

    NCT00148486

    Jun 2003 to Mar 2005 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NS 2330Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined

    Time frame · baseline and 14 Weeks

  2. Proportion of patients who were withdrawn from the study due to AEs

    Time frame · baseline and 14 Weeks

Secondary outcomes(16)

  1. Mean change in Part I, Part II, and Part III (separately) of the UPDRS

    Time frame · 14 weeks

  2. Mean change in the Clinical Global Impressions (CGI)-Severity scale

    Time frame · 14 weeks

  3. Mean change in the Modified Hoehn and Yahr Scale (MHYS)

    Time frame · 14 weeks

  4. Mean change in the Modified Schwab-England Disability Scale (MSED)

    Time frame · 14 weeks

  5. 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

  6. 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

  7. Mean change in the Auditory Verbal Learning Test (AVLT)

    Time frame · 14 weeks

  8. mean score at Week 14 on the CGI-Improvement (which has no baseline rating)

    Time frame · 14 weeks

  9. Proportion of responder patients (20% and 30% improved on the total score of the UPDRS)

    Time frame · 14 weeks

  10. Incidence of adverse events

    Time frame · 2 weeks

  11. vital signs (blood pressure and pulse rate)

    Time frame · 20 weeks

  12. patients with abnormal laboratory test measurements

    Time frame · 20 weeks

  13. patients with abnormalities in electrocardiograms (ECGs)

    Time frame · 20 weeks

  14. Epworth Sleepiness Scale (ESS) (for daytime sleepiness)

    Time frame · 20 weeks

  15. Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep

    Time frame · 20 weeks

  16. Drug plasma concentration

    Time frame · 20 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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