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
- Conditions
- Parkinson Disease
- Registration Number
- NCT00148512
- Lead Sponsor
- Boehringer Ingelheim
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method UPDRS parts II (averaged "on" and "off") 14 weeks "Off" time during waking hours 14 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (40)
Paracelsus-Elena-Klinik
馃嚛馃嚜Kassel, Germany
Univ.-Klinik f眉r Neurologie
馃嚘馃嚬Innsbruck, Austria
H么pital Gabriel Montpied
馃嚝馃嚪Clermont Ferrand, France
Christian Albrechts Universit盲t zu Kiel
馃嚛馃嚜Kiel, Germany
H么pital Purpan
馃嚝馃嚪Toulouse cedex 7, France
Service de Neurologie
馃嚝馃嚪Paris, France
St. Josef-Hospital
馃嚛馃嚜Bochum, Germany
AKH der Stadt Linz
馃嚘馃嚬Linz, Austria
Hospital Clinic i Provincial de BCN
馃嚜馃嚫Barcelona, Spain
Landesklinikum St. P枚lten
馃嚘馃嚬St. P枚lten, Austria
Neurology Research
馃嚞馃嚙Stoke-On-Trent, United Kingdom
Hospital Gregorio Mara帽贸n
馃嚜馃嚫Madrid, Spain
H么pital Pierre Wertheimer
馃嚝馃嚪Bron cedex, France
H么pital du Pays d'Aix
馃嚝馃嚪Aix en Provence, France
Krankenhaus d. Barmherzigen Br眉der Graz-Eggenberg
馃嚘馃嚬Graz, Austria
H么pital Guillaume et Ren茅 Laennec
馃嚝馃嚪Saint Herblain, France
H么pital du Haut-Lev猫que
馃嚝馃嚪Pessac, France
Universit盲tsklinik Rostock
馃嚛馃嚜Rostock, Germany
Boehringer Ingelheim Investigational Site
馃嚦馃嚤Utrecht, Netherlands
Centre Hospitalier Universitaire JB Miletrie
馃嚝馃嚪Poitiers cedex, France
Deutsche Klinik f眉r Diagnostik GmbH
馃嚛馃嚜Wiesbaden, Germany
Regional Neurosciences Centre
馃嚞馃嚙Newcastle upon Tyne, United Kingdom
H么pital Roger Salengro
馃嚝馃嚪Lille cedex, France
Universit盲t Leipzig
馃嚛馃嚜Leipzig, Germany
H么pital de la Timone
馃嚝馃嚪Marseille, France
Universit盲tsklinikum der Humboldt-Universit盲t
馃嚛馃嚜Berlin, Germany
Hospital Vall d'Hebr贸n
馃嚜馃嚫Barcelona, Spain
Hospital de la Sta. Creu i Sant Pau
馃嚜馃嚫Barcelona, Spain
Landesnervenklinik Wagner Jauregg Linz
馃嚘馃嚬Linz, Austria
Universit盲tsklinikum Ulm
馃嚛馃嚜Ulm, Germany
Hospital Cl铆nico niversitario de Santiago de Compostela
馃嚜馃嚫Santiago de Compostela, Spain
City Hospital
馃嚞馃嚙Birmingham, United Kingdom
Neurology Department
馃嚞馃嚙Swansea, United Kingdom
Martini ziekenhuis
馃嚦馃嚤Groningen, Netherlands
Klinik f眉r Neurologie
馃嚛馃嚜Marburg, Germany
Klinikum Gro脽hadern der L.M.-Universit盲t
馃嚛馃嚜M眉nchen, Germany
Locatie Willem-Alexander
馃嚦馃嚤's-Hertogenbosch, Netherlands
Maasland Ziekenhuis
馃嚦馃嚤Sittard, Netherlands
Hospital Cl铆nico Universitario V铆rgen de la Macarena
馃嚜馃嚫Sevilla, Spain
Walton Centre for Neurology
馃嚞馃嚙Liverpool, United Kingdom