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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NS 2330 | Drug |
| 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| Proportion of patients who were withdrawn from the study due to AEs | baseline and 14 Weeks |
| 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 | |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Reaserch Centers | Peoria | Arizona | United States | |||
| Boehringer Ingelheim Investigational Site |
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| 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 |
| Tucson |
| Arizona |
| United States |
| PMDI | Fountain Valley | California | United States |
| Boehringer Ingelheim Investigational Site | Fresno | California | United States |
| Boehringer Ingelheim Investigational Site | Irvine | California | United States |
| Boehringer Ingelheim Investigational Site | Ocenside | California | United States |
| Boehringer Ingelheim Investigational Site | Oxnard | California | United States |
| West Los Angeles VA Medical Center | West Los Angeles | California | United States |
| Boehringer Ingelheim Investigational Site | Danbury | Connecticut | United States |
| UCONN Health Center | Farmington | Connecticut | United States |
| 60 Temple St | New Haven | Connecticut | United States |
| Boehringer Ingelheim Investigational Site | Boca Raton | Florida | United States |
| Boehringer Ingelheim Investigational Site | Bradenton | Florida | United States |
| University of Florida | Gainsville | Florida | United States |
| Sunrise Clinical Research | Hollywood | Florida | United States |
| Department of Neurology | Miami | Florida | United States |
| Miami Research Associates | Miami | Florida | United States |
| Boehringer Ingelheim Investigational Site | Ocala | Florida | United States |
| Renstar Medical Research | Ocala | Florida | United States |
| Boehringer Ingelheim Investigational Site | Panama City | Florida | United States |
| CNS Clinical Trials | Saint Piresburg | Florida | United States |
| Movement Disorder Center | Tampa | Florida | United States |
| University of Southern Florida | Tampa | Florida | United States |
| Department of Neurological Sciences | Chicago | Illinois | United States |
| Boehringer Ingelheim Investigational Site | Fort Wayne | Indiana | United States |
| Outpatient Clinical Research Facility | Indianapolis | Indiana | United States |
| Boehringer Ingelheim Investigational Site | Kansas City | Kansas | United States |
| Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States |
| Boehringer Ingelheim Investigational Site | Scarborough | Maine | United States |
| Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | United States |
| Future Care Studies | Springfield | Massachusetts | United States |
| Boehringer Ingelheim Investigational Site | Traverse City | Michigan | United States |
| Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States |
| University of Minesota | Minneapolis | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | United States |
| Global Medical Institutes LLC | Toms River | New Jersey | United States |
| Upstate Clinical Resaerch LLC | Albany | New York | United States |
| Boehringer Ingelheim Investigational Site | New York | New York | United States |
| Boehringer Ingelheim Investigational Site | Wiston-Salem | North Carolina | United States |
| Ohio State University Medical Center | Columbus | Ohio | United States |
| Neurology Specialists Inc. | Dayton | Ohio | United States |
| St. John's Doctor Building | Tulsa | Oklahoma | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| The Methodist Hospital | Houston | Texas | United States |
| Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| North Texas Neurology Associates | Wichita Falls | Texas | United States |
| University of Calgary | Calgary | Alberta | Canada |
| University of British Columbia | Vancouver | British Columbia | Canada |
| Davidson Memory Clinic | Moncton | New Brunswick | Canada |
| Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada |
| Centre For Movement Disorders | Markham | Ontario | Canada |
| Clinical Research Consultant Group | Beaconsfield | Quebec | Canada |
| Memory and Motor Skills Disorders Clinic | Québec | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C518479 | Tesofensine |
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