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Completed

NCT Number: NCT00148486

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NS 2330

Drug

Primary outcomes

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 Proportion of patients who were withdrawn from the study due to AEs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

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
First posted
Sep 8, 2005
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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