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
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
- Univ.-Klinik für Neurologie
- Univ.-Klinik für Neurologie
- Landesnervenklinik Wagner Jauregg Linz
- AKH der Stadt Linz
- Landesklinikum St. Pölten
- Hôpital du Pays d'Aix
- Hôpital Pierre Wertheimer
- Hôpital Gabriel Montpied
- Hôpital Roger Salengro
- Hôpital de la Timone
- Service de Neurologie
- Hôpital du Haut-Levèque
- Centre Hospitalier Universitaire JB Miletrie
- Hôpital Guillaume et René Laennec
- Hôpital Purpan
- Universitätsklinikum der Humboldt-Universität
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- St. Josef-Hospital
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Paracelsus-Elena-Klinik
- Christian Albrechts Universität zu Kiel
- Universität Leipzig
- Klinik für Neurologie
- Klinikum Großhadern der L.M.-Universität
- Universitätsklinik Rostock
- Universitätsklinikum Ulm
- Deutsche Klinik für Diagnostik GmbH
- Locatie Willem-Alexander
- Boehringer Ingelheim Investigational Site
- Martini ziekenhuis
- Maasland Ziekenhuis
- Boehringer Ingelheim Investigational Site
- Hospital Vall d'Hebrón
- Hospital Clinic i Provincial de BCN
- Hospital de la Sta. Creu i Sant Pau
- Hospital Gregorio Marañón
- Hospital Clínico niversitario de Santiago de Compostela
- Hospital Clínico Universitario Vírgen de la Macarena
- City Hospital
- Neurology Department
- Neurology Department
- Walton Centre for Neurology
- Regional Neurosciences Centre
- Neurology Research
- Neurology Department