Parkinson Disease
Conditions
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.
Interventions
DRUGNS 2330
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | 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| Proportion of patients who were withdrawn from the study due to AEs | baseline and 14 Weeks |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
| Measure | Time frame |
|---|---|
| Mean change in the Modified Hoehn and Yahr Scale (MHYS) | 14 weeks |
| Mean change in Part I, Part II, and Part III (separately) of the UPDRS | 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 |
| Mean change in the Modified Schwab-England Disability Scale (MSED) | 14 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 |
| Incidence of adverse events | 2 weeks |
| Mean change in the Clinical Global Impressions (CGI)-Severity scale | 14 weeks |
Countries
Canada, United States
Outcome results
None listed