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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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00148512
Collaborator
(none)
254
Enrollment
50
Locations
23.1
Duration (Months)
5.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 1. Tesofensine (NS 2330)
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
254 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Feb 1, 2005
Study Completion Date :
Feb 1, 2005

Outcome Measures

Primary Outcome Measures

  1. UPDRS parts II (averaged "on" and "off") [14 weeks]

  2. "Off" time during waking hours [14 weeks]

Secondary Outcome Measures

  1. Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia [14 weeks]

  2. Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores [14 weeks]

  3. Clinical Global Impressions (CGI) Improvement and Severity [14 weeks]

  4. Auditory Verbal Learning test (AVLT) [14 weeks]

  5. Modified Schwab and England Disability scale [14 weeks]

  6. Snaith-Hamilton Pleasure Scale (SHAPS) [14 weeks]

  7. Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours [14 weeks]

  8. Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score [14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
42 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg Graz Austria 8020
2 Univ.-Klinik für Neurologie Graz Austria 8036
3 Univ.-Klinik für Neurologie Innsbruck Austria 6020
4 Landesnervenklinik Wagner Jauregg Linz Linz Austria 4020
5 AKH der Stadt Linz Linz Austria 4021
6 Landesklinikum St. Pölten St. Pölten Austria 3100
7 Hôpital du Pays d'Aix Aix en Provence France 13616
8 Hôpital Pierre Wertheimer Bron cedex France 69677
9 Hôpital Gabriel Montpied Clermont Ferrand France 63003
10 Hôpital Roger Salengro Lille cedex France 59037
11 Hôpital de la Timone Marseille France 13385
12 Service de Neurologie Paris France 75013
13 Hôpital du Haut-Levèque Pessac France 33604
14 Centre Hospitalier Universitaire JB Miletrie Poitiers cedex France 86021
15 Hôpital Guillaume et René Laennec Saint Herblain France 44800
16 Hôpital Purpan Toulouse cedex 7 France 31073
17 Universitätsklinikum der Humboldt-Universität Berlin Germany 10117
18 Boehringer Ingelheim Investigational Site Berlin Germany 10178
19 Boehringer Ingelheim Investigational Site Berlin Germany 12163
20 Boehringer Ingelheim Investigational Site Berlin Germany 12167
21 Boehringer Ingelheim Investigational Site Berlin Germany 13507
22 St. Josef-Hospital Bochum Germany 44791
23 Boehringer Ingelheim Investigational Site Gera Germany 07551
24 Boehringer Ingelheim Investigational Site Herborn Germany 35745
25 Paracelsus-Elena-Klinik Kassel Germany 34128
26 Christian Albrechts Universität zu Kiel Kiel Germany 24105
27 Universität Leipzig Leipzig Germany 04103
28 Klinik für Neurologie Marburg Germany 35033
29 Klinikum Großhadern der L.M.-Universität München Germany 81377
30 Universitätsklinik Rostock Rostock Germany 18147
31 Universitätsklinikum Ulm Ulm Germany 89075
32 Deutsche Klinik für Diagnostik GmbH Wiesbaden Germany 65191
33 Locatie Willem-Alexander 's-Hertogenbosch Netherlands 5223 GV
34 Boehringer Ingelheim Investigational Site Breda Netherlands 4818 CK
35 Martini ziekenhuis Groningen Netherlands 9728 RM
36 Maasland Ziekenhuis Sittard Netherlands 6163 BK
37 Boehringer Ingelheim Investigational Site Utrecht Netherlands 3584 CX
38 Hospital Vall d'Hebrón Barcelona Spain 08035
39 Hospital Clinic i Provincial de BCN Barcelona Spain 08036
40 Hospital de la Sta. Creu i Sant Pau Barcelona Spain 08041
41 Hospital Gregorio Marañón Madrid Spain 28007
42 Hospital Clínico niversitario de Santiago de Compostela Santiago de Compostela Spain 15706
43 Hospital Clínico Universitario Vírgen de la Macarena Sevilla Spain 41071
44 City Hospital Birmingham United Kingdom B18 7QH
45 Neurology Department Blackburn United Kingdom BB2 3L0
46 Neurology Department Glasgow United Kingdom G51 4TF
47 Walton Centre for Neurology Liverpool United Kingdom L9 7LJ
48 Regional Neurosciences Centre Newcastle upon Tyne United Kingdom NE4 6BE
49 Neurology Research Stoke-On-Trent United Kingdom ST4 7LN
50 Neurology Department Swansea United Kingdom 6AS 6NL

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, BI France S.A.S.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00148512
Other Study ID Numbers:
  • 1198.101
First Posted:
Sep 8, 2005
Last Update Posted:
Oct 29, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Oct 29, 2013