Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924153
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-06-08
Brief Title:
A Natural History Study of Participants With Potassium Sodium-Activated Channel Subfamily T Member 1 KCNT1-Related Epilepsy
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Non-Drug Longitudinal Prospective Natural History Study of Individuals With KCNT1-Related Epilepsy K1Te
Status:
COMPLETED
Status Verified Date:
2024-02
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:
K1Te
Brief Summary:
The primary objective of the study is to characterize seizures in participants with KCNT1-related epilepsy The secondary objectives are to characterize head growth symptom severity neurocognitive and social functions adaptive behavior sleep quality of life caregiver burden and mood in participants with KCNT1-related epilepsy
Detailed Description:
None
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