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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148512

  Show 50 Study Locations
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 23, 2014