Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03103399
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2017-03-28
Brief Title:
Efficacy and Tolerability of Nebicapone in Parkinsons Disease Patients With Wearingoff Phenomenon
Sponsor:
Bial - Portela C SA
Organization:
Bial - Portela C SA
Study Overview
Official Title:
A Multicentre Double-blind Randomised Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinsons Disease Patients With Wearingoff Phenomenon Treated With LevodopaCarbidopa or LevodopaBenserazide
Status:
COMPLETED
Status Verified Date:
2017-03
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 purpose of this study was to investigate the effect on the wearing-off phenomenon of 3 different doses of nebicapone NEB 50 mg 100 mg and 150 mg compared with entacapone and placebo when dministered concomitantly with existing treatment with levodopa plus a dopa decarboxylase inhibitor DDCI carbidopa or benserazide
Detailed Description:
The study was conducted in 40 sites in Europe and South America Argentina 6 Austria 2 Brazil 5 France 1 Hungary 4 Poland 7 Portugal 2 Romania 7 and Ukraine 6
Multicentre study with a screening visit Visit V1 a single-blind placebo run-in period of 1 or 2 weeks Period 1 Visits V2 to V3 and an 8-week randomised double-blind activeand placebo-controlled parallel-group 5 groups treatment period Period 2 Visits V3 to V7 In Hungary only a 1-week tapering-off period was added by amendment 1HU The dosage of nebicapone was to be tapered off stepwise during 6 days This period was to end with a follow-up Visit V8
Multicentre study with a screening visit Visit V1 a single-blind placebo run-in period of 1 or 2 weeks Period 1 Visits V2 to V3 and an 8-week randomised double-blind activeand placebo-controlled parallel-group 5 groups treatment period Period 2 Visits V3 to V7 In Hungary only a 1-week tapering-off period was added by amendment 1HU The dosage of nebicapone was to be tapered off stepwise during 6 days This period was to end with a follow-up Visit V8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None