• There are two co-primary efficacy outcomes in this study: change in percent off-time during waking hours (based on reports from patient's diary) and change in UPDRS II+III total score
  

• Percent on time without dyskinesia, or with non troublesome dysk., or both, or with troublesome dysk.
  
• Each of UPDRS I to IV sub-scores separately
  
• CGI-Improvement and Severity
  
• AVLT
  
• Modified Schwab and England Disability scale
  
• SHAPS
  
• % responders
  

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.

The alternative hypothesis is that treatment with tesofensine is superior to treatment with placebo.

Comparison(s):

For the primary comparison between tesofensine and placebo, change in percentage off-time during waking hours will be based on reports from patient's diary (completed at day -3 and day-2 prior to the study visits) and change in the UPDRS II+III will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits.