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 - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00148512

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 II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Tesofensine NS 2330

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Double-Blind Placebo-Controlled Five Parallel-Group Efficacy and Safety Exploratory Study of NS 2330 (0.125mg, 0.25mg, 0.5mg 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 Pa

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	250
Study Start Date:	March 2003
Estimated Study Completion Date:	February 2005

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

Show 50 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

BI France S.A.S.

More Information

Publications indexed to this study:

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.

Study ID Numbers:	1198.101
Study First Received:	September 7, 2005
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00148512
Health Authority:	France: AFSSAPS; Austria: BMGF; Germany: BfArM; Spain: AEMPS; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: MEB

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009