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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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
1. Tesofensine (NS 2330)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

42 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia
Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores
Clinical Global Impressions (CGI) Improvement and Severity
Auditory Verbal Learning test (AVLT)
Modified Schwab and England Disability scale
Snaith-Hamilton Pleasure Scale (SHAPS)
Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours
Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score

Full Information

First Posted
September 7, 2005
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00148512
Brief Title
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
Official Title
A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (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 (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
1. Tesofensine (NS 2330)
Primary Outcome Measure Information:
Title
UPDRS parts II (averaged "on" and "off")
Time Frame
14 weeks
Title
"Off" time during waking hours
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia
Time Frame
14 weeks
Title
Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores
Time Frame
14 weeks
Title
Clinical Global Impressions (CGI) Improvement and Severity
Time Frame
14 weeks
Title
Auditory Verbal Learning test (AVLT)
Time Frame
14 weeks
Title
Modified Schwab and England Disability scale
Time Frame
14 weeks
Title
Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame
14 weeks
Title
Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours
Time Frame
14 weeks
Title
Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
BI France S.A.S.
Official's Role
Study Chair
Facility Information:
Facility Name
Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Univ.-Klinik für Neurologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Univ.-Klinik für Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landesnervenklinik Wagner Jauregg Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AKH der Stadt Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Landesklinikum St. Pölten
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Hôpital du Pays d'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Service de Neurologie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital du Haut-Levèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire JB Miletrie
City
Poitiers cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Hôpital Guillaume et René Laennec
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Hôpital Purpan
City
Toulouse cedex 7
ZIP/Postal Code
31073
Country
France
Facility Name
Universitätsklinikum der Humboldt-Universität
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10178
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
12167
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Gera
ZIP/Postal Code
07551
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Herborn
ZIP/Postal Code
35745
Country
Germany
Facility Name
Paracelsus-Elena-Klinik
City
Kassel
ZIP/Postal Code
34128
Country
Germany
Facility Name
Christian Albrechts Universität zu Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinik für Neurologie
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Klinikum Großhadern der L.M.-Universität
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinik Rostock
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik GmbH
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Locatie Willem-Alexander
City
's-Hertogenbosch
ZIP/Postal Code
5223 GV
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Martini ziekenhuis
City
Groningen
ZIP/Postal Code
9728 RM
Country
Netherlands
Facility Name
Maasland Ziekenhuis
City
Sittard
ZIP/Postal Code
6163 BK
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de BCN
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Sta. Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clínico niversitario de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Clínico Universitario Vírgen de la Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
City Hospital
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Neurology Department
City
Blackburn
ZIP/Postal Code
BB2 3L0
Country
United Kingdom
Facility Name
Neurology Department
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Walton Centre for Neurology
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Regional Neurosciences Centre
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Neurology Research
City
Stoke-On-Trent
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Neurology Department
City
Swansea
ZIP/Postal Code
6AS 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18474731
Citation
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.
Results Reference
derived

Learn more about this trial

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

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