Status:
COMPLETED
A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Eligibility:
All Genders
42-80 years
Phase:
PHASE2
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 per...
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 fluctuation...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Male or female patient with idiopathic Parkinson Disease (PD) diagnosed for at least 2 years.
- Patient aged 40 years or over at time of diagnosis of PD and not older than 80 years at screening visit.
- Modified Hoehn and Yahr stage of II to III at "on" time.
- Treatment with Levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit.
- Motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.
- Main exclusion criteria:
- Neuropsychiatric exclusions: Non-idiopathic PD, dementia (Mini Mental State Exam \<26), history of psychosis, history or current Axis I or Axis II mental disorder according to DSM-IV, etc
- Other medical exclusions, like ECG abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc
- Pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00148512
Start Date
March 1 2003
End Date
February 1 2005
Last Update
October 29 2013
Active Locations (50)
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1
Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
Graz, Austria, 8020
2
Univ.-Klinik für Neurologie
Graz, Austria, 8036
3
Univ.-Klinik für Neurologie
Innsbruck, Austria, 6020
4
Landesnervenklinik Wagner Jauregg Linz
Linz, Austria, 4020