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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00148512
First received: September 7, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Parkinson Disease
Drug: 1. Tesofensine (NS 2330)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • UPDRS parts II (averaged "on" and "off") [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • "Off" time during waking hours [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions (CGI) Improvement and Severity [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Auditory Verbal Learning test (AVLT) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Modified Schwab and England Disability scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: March 2003
Estimated Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   42 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148512

  Hide Study Locations
Locations
Austria
Univ.-Klinik für Neurologie
Graz, Austria, 8036
Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
Graz, Austria, 8020
Univ.-Klinik für Neurologie
Innsbruck, Austria, 6020
AKH der Stadt Linz
Linz, Austria, 4021
Landesnervenklinik Wagner Jauregg Linz
Linz, Austria, 4020
Landesklinikum St. Pölten
St. Pölten, Austria, 3100
France
Hôpital du Pays d'Aix
Aix en Provence, France, 13616
Hôpital Pierre Wertheimer
Bron cedex, France, 69677
Hôpital Gabriel Montpied
Clermont Ferrand, France, 63003
Hôpital Roger Salengro
Lille cedex, France, 59037
Hôpital de la Timone
Marseille, France, 13385
Service de Neurologie
Paris, France, 75013
Hôpital du Haut-Levèque
Pessac, France, 33604
Centre Hospitalier Universitaire JB Miletrie
Poitiers cedex, France, 86021
Hôpital Guillaume et René Laennec
Saint Herblain, France, 44800
Hôpital Purpan
Toulouse cedex 7, France, 31073
Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany, 12167
Boehringer Ingelheim Investigational Site
Berlin, Germany, 13507
Universitätsklinikum der Humboldt-Universität
Berlin, Germany, 10117
Boehringer Ingelheim Investigational Site
Berlin, Germany, 10178
Boehringer Ingelheim Investigational Site
Berlin, Germany, 12163
St. Josef-Hospital
Bochum, Germany, 44791
Boehringer Ingelheim Investigational Site
Gera, Germany, 07551
Boehringer Ingelheim Investigational Site
Herborn, Germany, 35745
Paracelsus-Elena-Klinik
Kassel, Germany, 34128
Christian Albrechts Universität zu Kiel
Kiel, Germany, 24105
Universität Leipzig
Leipzig, Germany, 04103
Klinik für Neurologie
Marburg, Germany, 35033
Klinikum Großhadern der L.M.-Universität
München, Germany, 81377
Universitätsklinik Rostock
Rostock, Germany, 18147
Universitätsklinikum Ulm
Ulm, Germany, 89075
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany, 65191
Netherlands
Locatie Willem-Alexander
's-Hertogenbosch, Netherlands, 5223 GV
Boehringer Ingelheim Investigational Site
Breda, Netherlands, 4818 CK
Martini ziekenhuis
Groningen, Netherlands, 9728 RM
Maasland Ziekenhuis
Sittard, Netherlands, 6163 BK
Boehringer Ingelheim Investigational Site
Utrecht, Netherlands, 3584 CX
Spain
Hospital Vall d'Hebrón
Barcelona, Spain, 08035
Hospital Clinic i Provincial de BCN
Barcelona, Spain, 08036
Hospital de la Sta. Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Clínico niversitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Hospital Clínico Universitario Vírgen de la Macarena
Sevilla, Spain, 41071
United Kingdom
City Hospital
Birmingham, United Kingdom, B18 7QH
Neurology Department
Blackburn, United Kingdom, BB2 3L0
Neurology Department
Glasgow, United Kingdom, G51 4TF
Walton Centre for Neurology
Liverpool, United Kingdom, L9 7LJ
Regional Neurosciences Centre
Newcastle upon Tyne, United Kingdom, NE4 6BE
Neurology Research
Stoke-On-Trent, United Kingdom, ST4 7LN
Neurology Department
Swansea, United Kingdom, 6AS 6NL
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S.
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00148512     History of Changes
Other Study ID Numbers: 1198.101
Study First Received: September 7, 2005
Last Updated: October 28, 2013
Health Authority: France: AFSSAPS
Austria: BMGF
Germany: BfArM
Spain: AEMPS
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: MEB

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 15, 2014