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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

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

September 7, 2005
October 28, 2013
March 2003
February 2005   (final data collection date for primary outcome measure)
  • 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 ]
There are two co-primary efficacy outcomes in this study: change in percent off-time during waking hours (based on reports from patient's diary) and change in UPDRS II+III total score
Complete list of historical versions of study NCT00148512 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percent on time without dyskinesia, or with non troublesome dysk., or both, or with troublesome dysk.
  • Each of UPDRS I to IV sub-scores separately
  • CGI-Improvement and Severity
  • AVLT
  • Modified Schwab and England Disability scale
  • SHAPS
  • % responders
Not Provided
Not Provided
 
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
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)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson Disease
Drug: 1. Tesofensine (NS 2330)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
February 2005
February 2005   (final data collection date for primary outcome measure)

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
Both
42 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Netherlands,   Spain,   United Kingdom
 
NCT00148512
1198.101
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S.
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP