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)

Boehringer Ingelheim261 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

261

Conditions

Parkinson Disease

Interventions

NS 2330DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (55)

Outcomes

Primary Outcomes

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Proportion of patients who were withdrawn from the study due to AEs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

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

Data from ClinicalTrials.gov

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Pivotal Reaserch Centers

Peoria, Arizona, United States