Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-31 @ 9:02 PM
Study NCT ID:
NCT07221968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin for the Treatment of DEE-SWAS
Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Organization:
Study Overview
Official Title:
Melatonin for the Treatment of Developmental/Epileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
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 goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use.
The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.
The study will look at the ways melatonin affects normal brain activity that occurs in sleep.
The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.
The study will look at the ways melatonin affects normal brain activity that occurs in sleep.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: