Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148512
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2005-09-07
Brief Title:
A Randomized Double-blind Placebo-controlled Five Parallel Groups Efficacy and Safety Study of NS 2330 Tesofensine 0125 mg 025 mg 05 mg and 10 mg Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 0125 mg 025 mg 05 mg and 10 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
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses from 0125 mg to 10 mg in comparison to placebo over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations
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 0125mg 025mg 050 mg or 10 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 IIIII 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
Comparisons
For the primary comparison between tesofensine and placebo change in percentage off-time during waking hours will be based on reports from patients diary completed at day -3 and day-2 prior to the study visits and change in the UPDRS IIIII will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits
Patients will be treated either with one of the 4 doses of tesofensine 0125mg 025mg 050 mg or 10 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 IIIII 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
Comparisons
For the primary comparison between tesofensine and placebo change in percentage off-time during waking hours will be based on reports from patients diary completed at day -3 and day-2 prior to the study visits and change in the UPDRS IIIII will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None