Clinical trial 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)
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 261
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from Baseline to Week 14 in the score of the UPDRS, Parts I-III combined
timeFrame: baseline and 14 Weeks
measure: Proportion of patients who were withdrawn from the study due to AEs
timeFrame: baseline and 14 Weeks
Secondary outcomes:
measure: Mean change in Part I, Part II, and Part III (separately) of the UPDRS
timeFrame: 14 weeks
measure: Mean change in the Clinical Global Impressions (CGI)-Severity scale
timeFrame: 14 weeks
measure: Mean change in the Modified Hoehn and Yahr Scale (MHYS)
timeFrame: 14 weeks
measure: Mean change in the Modified Schwab-England Disability Scale (MSED)
timeFrame: 14 weeks
measure: 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)
timeFrame: 14 weeks
measure: 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)
timeFrame: 14 weeks
measure: Mean change in the Auditory Verbal Learning Test (AVLT)
timeFrame: 14 weeks
measure: mean score at Week 14 on the CGI-Improvement (which has no baseline rating)
timeFrame: 14 weeks
measure: Proportion of responder patients (20% and 30% improved on the total score of the UPDRS)
timeFrame: 14 weeks
measure: Incidence of adverse events
timeFrame: 2 weeks
measure: vital signs (blood pressure and pulse rate)
timeFrame: 20 weeks
measure: patients with abnormal laboratory test measurements
timeFrame: 20 weeks
measure: patients with abnormalities in electrocardiograms (ECGs)
timeFrame: 20 weeks
measure: Epworth Sleepiness Scale (ESS) (for daytime sleepiness)
timeFrame: 20 weeks
measure: Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep
timeFrame: 20 weeks
measure: Drug plasma concentration
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Reaserch Centers
state: Arizona
city: Tucson
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Fountain Valley
country: United States
facility: PMDI
state: California
city: Fresno
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Irvine
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Ocenside
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Oxnard
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: West Los Angeles
country: United States
facility: West Los Angeles VA Medical Center
state: California
city: Danbury
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: UCONN Health Center
state: Connecticut
city: New Haven
country: United States
facility: 60 Temple St
state: Connecticut
city: Boca Raton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research
state: Florida
city: Miami
country: United States
facility: Department of Neurology
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Ocala
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Panama City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: St. Piresburg
country: United States
facility: CNS Clinical Trials
state: Florida
city: Tampa
country: United States
facility: Movement Disorder Center
state: Florida
city: Tampa
country: United States
facility: University of Southern Florida
state: Florida
city: Chicago
country: United States
facility: Department of Neurological Sciences
state: Illinois
city: Fort Wayne
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Outpatient Clinical Research Facility
state: Indiana
city: Kansas City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Maine
city: Springfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: Traverse City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minesota
state: Minnesota
city: Omaha
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Toms River
country: United States
facility: Global Medical Institutes LLC
state: New Jersey
city: Albany
country: United States
facility: Upstate Clinical Resaerch LLC
state: New York
city: New York
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Wiston-Salem
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists Inc.
state: Ohio
city: Tulsa
country: United States
facility: St. John's Doctor Building
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: North Texas Neurology Associates
state: Texas
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Moncton
country: Canada
facility: Davidson Memory Clinic
state: New Brunswick
city: Halifax
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Markham
country: Canada
facility: Centre For Movement Disorders
state: Ontario
city: Beaconsfield
country: Canada
facility: Clinical Research Consultant Group
state: Quebec
city: Saskatoon
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Memory and Motor Skills Disorders Clinic
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: