A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 254
- Locations
- 90
- Primary Endpoint
- UPDRS parts II (averaged "on" and "off")
Study Overview
Brief Summary
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.
Detailed Description
This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with motor fluctuations.
Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks.
The two co-primary efficacy endpoints are the change in off-time and the change in the Unified Parkinson Disease Rating Scale (UPDRS) II+III total score
Study Hypothesis:
The null hypothesis is that there is no difference between placebo and tesofensine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 42 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
UPDRS parts II (averaged "on" and "off")
Time Frame: 14 weeks
"Off" time during waking hours
Time Frame: 14 weeks
Secondary Outcomes
- Modified Schwab and England Disability scale(14 weeks)
- Snaith-Hamilton Pleasure Scale (SHAPS)(14 weeks)
- Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours(14 weeks)
- Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score(14 weeks)
- Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia(14 weeks)
- Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores(14 weeks)
- Clinical Global Impressions (CGI) Improvement and Severity(14 weeks)
- Auditory Verbal Learning test (AVLT)(14 weeks)