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Trial · Interventional

CompletedPhase 2Registry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
254 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Double masking
Countries
6 countries

Austria, France, Germany, Netherlands, Spain, United Kingdom

Start
Mar 2003
Primary completion
Feb 2005
Completion
Feb 2005
First posted
8 Sept 2005 (estimated)
Last update posted
29 Oct 2013 (estimated)
Conditions
Parkinson Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2003200420052006
  1. Ph 2

    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

    NCT00148512

    Mar 2003 to Feb 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 1. Tesofensine (NS 2330)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. UPDRS parts II (averaged "on" and "off")

    Time frame · 14 weeks

  2. "Off" time during waking hours

    Time frame · 14 weeks

Secondary outcomes(8)
  1. Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia

    Time frame · 14 weeks

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

    Time frame · 14 weeks

  3. Clinical Global Impressions (CGI) Improvement and Severity

    Time frame · 14 weeks

  4. Auditory Verbal Learning test (AVLT)

    Time frame · 14 weeks

  5. Modified Schwab and England Disability scale

    Time frame · 14 weeks

  6. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame · 14 weeks

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

    Time frame · 14 weeks

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

    Time frame · 14 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

6 results

Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study.

Rascol et al. 2008Archives of neurologycited by 27

PMID 18474731DOI 10.1001/archneur.65.5.577PUB-18474731

Full text at the publisher6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 42 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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