Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462007
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2007-04-17
Brief Title:
Study to Evaluate Initiation of Stalevo in Early Wearing-off
Sponsor:
Orion Corporation Orion Pharma
Organization:
Orion Corporation Orion Pharma
Study Overview
Official Title:
Efficacy and Safety of Stalevo in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9 an Open Non-randomised Multinational Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinsons Disease Patients
Status:
COMPLETED
Status Verified Date:
2015-04
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:
SENSE
Brief Summary:
An open non-randomised multinational multicentre direct switch study in levodopa-treated Parkinsons disease patients suffering from early wearing-off in Parkinsons disease The study will consist of 2 consecutive periods screening period and study treatment period Duration of the study will be up to 8 weeks for each subject The study treatment dosage will be determined by the subjects current separately administered standard levodopaDDCI treatment 3-4 doses per day maximum of total daily dose of 600 mg levodopa which will be switched to an equivalent dose of Stalevo without changing the number of doses per day The levodopa daily dose during Stalevo treatment may be adjusted according to the study subjects clinical response
Detailed Description:
See Brief summary
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