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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

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ClinicalTrials.gov Identifier: NCT00148512
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 29, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

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
Parkinson Disease 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 Type : Interventional  (Clinical Trial)
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 : March 2003
Primary Completion Date : February 2005
Estimated Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources




Primary Outcome Measures :
  1. UPDRS parts II (averaged "on" and "off") [ Time Frame: 14 weeks ]
  2. "Off" time during waking hours [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   42 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148512


  Show 50 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S.

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
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs