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
NCT ID: NCT00148512
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2003-03-31
2005-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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1. Tesofensine (NS 2330)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
42 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BI France S.A.S.
Locations
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Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
Graz, , Austria
Univ.-Klinik für Neurologie
Graz, , Austria
Univ.-Klinik für Neurologie
Innsbruck, , Austria
Landesnervenklinik Wagner Jauregg Linz
Linz, , Austria
AKH der Stadt Linz
Linz, , Austria
Landesklinikum St. Pölten
Sankt Pölten, , Austria
Hôpital du Pays d'Aix
Aix-en-Provence, , France
Hôpital Pierre Wertheimer
Bron, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Hôpital Roger Salengro
Lille, , France
Hôpital de la Timone
Marseille, , France
Service de Neurologie
Paris, , France
Hôpital du Haut-Levèque
Pessac, , France
Centre Hospitalier Universitaire JB Miletrie
Poitiers, , France
Hôpital Guillaume et René Laennec
Saint-Herblain, , France
Hôpital Purpan
Toulouse, , France
Universitätsklinikum der Humboldt-Universität
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
St. Josef-Hospital
Bochum, , Germany
Boehringer Ingelheim Investigational Site
Gera, , Germany
Boehringer Ingelheim Investigational Site
Herborn, , Germany
Paracelsus-Elena-Klinik
Kassel, , Germany
Christian Albrechts Universität zu Kiel
Kiel, , Germany
Universität Leipzig
Leipzig, , Germany
Klinik für Neurologie
Marburg, , Germany
Klinikum Großhadern der L.M.-Universität
München, , Germany
Universitätsklinik Rostock
Rostock, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, , Germany
Locatie Willem-Alexander
's-Hertogenbosch, , Netherlands
Boehringer Ingelheim Investigational Site
Breda, , Netherlands
Martini ziekenhuis
Groningen, , Netherlands
Maasland Ziekenhuis
Sittard, , Netherlands
Boehringer Ingelheim Investigational Site
Utrecht, , Netherlands
Hospital Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic i Provincial de BCN
Barcelona, , Spain
Hospital de la Sta. Creu i Sant Pau
Barcelona, , Spain
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Clínico niversitario de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Clínico Universitario Vírgen de la Macarena
Seville, , Spain
City Hospital
Birmingham, , United Kingdom
Neurology Department
Blackburn, , United Kingdom
Neurology Department
Glasgow, , United Kingdom
Walton Centre for Neurology
Liverpool, , United Kingdom
Regional Neurosciences Centre
Newcastle upon Tyne, , United Kingdom
Neurology Research
Stoke-on-Trent, , United Kingdom
Neurology Department
Swansea, , United Kingdom
Countries
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References
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Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83. doi: 10.1001/archneur.65.5.577.
Other Identifiers
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1198.101
Identifier Type: -
Identifier Source: org_study_id