Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639620
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Study To Assess Effectiveness and Adverse Events of Foscarbidopa Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENVOL
Brief Summary:
Parkinsons disease PD is a neurological condition which affects the brain PD gets worse over time but how quickly it progresses varies a lot from person to person Some symptoms of PD are tremors stiffness and slowness of movement This study will assess how effective foscarbidopa foslevodopa is in treating French adult participants with advanced Parkinson disease under routine clinical practice
Foslevodopafoscarbidopa is an approved drug outside of US for the treatment of Parkinsons Disease Approximately 200 adult participants who are prescribed foslevodopafoscarbidopa by their doctors will be enrolled across approximately 30 sites in France
Participants will receive foscarbidopa foslevodopa subcutaneous infusion as prescribed by their physician Participants will be followed for up to 12 months
There is expected to be no additional burden for participants in this trial Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
Foslevodopafoscarbidopa is an approved drug outside of US for the treatment of Parkinsons Disease Approximately 200 adult participants who are prescribed foslevodopafoscarbidopa by their doctors will be enrolled across approximately 30 sites in France
Participants will receive foscarbidopa foslevodopa subcutaneous infusion as prescribed by their physician Participants will be followed for up to 12 months
There is expected to be no additional burden for participants in this trial Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
Detailed Description:
None
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