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 Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: NS 2330


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NS 2330|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined |  | baseline and 14 Weeks | 
| Proportion of patients who were withdrawn from the study due to AEs |  | baseline and 14 Weeks | 

Secondary Outcome Measures

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