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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

254

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline

Completed

Started Mar 2003

Geographic Reach

6 countries

50 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

March 1, 2003

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed

Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

1.9 years

First QC Date

September 7, 2005

Last Update Submit

October 28, 2013

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

UPDRS parts II (averaged "on" and "off")
14 weeks
"Off" time during waking hours
14 weeks

Secondary Outcomes (8)

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
Modified Schwab and England Disability scale
14 weeks
+3 more secondary outcomes

Interventions

1. Tesofensine (NS 2330)DRUG

Eligibility Criteria

Age42 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead

Study Sites (50)

Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg

Graz, 8020, Austria

Location

Univ.-Klinik für Neurologie

Graz, 8036, Austria

Location

Univ.-Klinik für Neurologie

Innsbruck, 6020, Austria

Location

Landesnervenklinik Wagner Jauregg Linz

Linz, 4020, Austria

Location

AKH der Stadt Linz

Linz, 4021, Austria

Location

Landesklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Hôpital du Pays d'Aix

Aix-en-Provence, 13616, France

Location

Hôpital Pierre Wertheimer

Bron, 69677, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Hôpital Roger Salengro

Lille, 59037, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Service de Neurologie

Paris, 75013, France

Location

Hôpital du Haut-Levèque

Pessac, 33604, France

Location

Centre Hospitalier Universitaire JB Miletrie

Poitiers, 86021, France

Location

Hôpital Guillaume et René Laennec

Saint-Herblain, 44800, France

Location

Hôpital Purpan

Toulouse, 31073, France

Location

Universitätsklinikum der Humboldt-Universität

Berlin, 10117, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10178, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 12163, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 12167, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 13507, Germany

Location

St. Josef-Hospital

Bochum, 44791, Germany

Location

Boehringer Ingelheim Investigational Site

Gera, 07551, Germany

Location

Boehringer Ingelheim Investigational Site

Herborn, 35745, Germany

Location

Paracelsus-Elena-Klinik

Kassel, 34128, Germany

Location

Christian Albrechts Universität zu Kiel

Kiel, 24105, Germany

Location

Universität Leipzig

Leipzig, 04103, Germany

Location

Klinik für Neurologie

Marburg, 35033, Germany

Location

Klinikum Großhadern der L.M.-Universität

München, 81377, Germany

Location

Universitätsklinik Rostock

Rostock, 18147, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Deutsche Klinik für Diagnostik GmbH

Wiesbaden, 65191, Germany

Location

Locatie Willem-Alexander

's-Hertogenbosch, 5223 GV, Netherlands

Location

Boehringer Ingelheim Investigational Site

Breda, 4818 CK, Netherlands

Location

Martini ziekenhuis

Groningen, 9728 RM, Netherlands

Location

Maasland Ziekenhuis

Sittard, 6163 BK, Netherlands

Location

Boehringer Ingelheim Investigational Site

Utrecht, 3584 CX, Netherlands

Location

Hospital Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de BCN

Barcelona, 08036, Spain

Location

Hospital de la Sta. Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clínico niversitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Clínico Universitario Vírgen de la Macarena

Seville, 41071, Spain

Location

City Hospital

Birmingham, B18 7QH, United Kingdom

Location

Neurology Department

Blackburn, BB2 3L0, United Kingdom

Location

Neurology Department

Glasgow, G51 4TF, United Kingdom

Location

Walton Centre for Neurology

Liverpool, L9 7LJ, United Kingdom

Location

Regional Neurosciences Centre

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Neurology Research

Stoke-on-Trent, ST4 7LN, United Kingdom

Location

Neurology Department

Swansea, 6AS 6NL, United Kingdom

Location

Related Publications (1)

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.
PMID: 18474731DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tesofensine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Boehringer Ingelheim Study Coordinator
BI France S.A.S.
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

March 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

DE(16)FR(10)AU(6)NL(5)GB(7)ES(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations