A Natural History Study of Participants With Potassium Sodium-Activated Channel Subfamily T Member 1 (KCNT1)-Related Epilepsy
NCT ID: NCT04924153
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2021-08-17
2023-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EIMFS and EOEE (Up to 2 years)
Participants who have been diagnosed with epilepsy of infancy with migrating focal seizures (EIMFS) and early-onset epileptic encephalopathy (EOEE) with duration of symptoms for up to 2 years will be enrolled.
No Intervention
Administered as specified in the treatment arm.
EIMFS and EOEE (More than 2 years)
Participants who have been diagnosed with EIMFS and EOEE with duration of symptoms for more than 2 years will be enrolled.
No Intervention
Administered as specified in the treatment arm.
SHE (Up to 2 years)
Participants who have been diagnosed with sleep-related hypermotor epilepsy (SHE) with duration of symptoms for up to 2 years will be enrolled.
No Intervention
Administered as specified in the treatment arm.
SHE (More than 2 years)
Participants who have been diagnosed with SHE with duration of symptoms for more than 2 years will be enrolled.
No Intervention
Administered as specified in the treatment arm.
Interventions
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No Intervention
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* Willingness of the participant and/or the participant's legally authorized representative (LAR) to comply with scheduled visits and study procedures.
Exclusion Criteria
* History of human immunodeficiency virus infection.
* History of central nervous system (CNS) tumors or malignancies, including CNS metastatic disease.
* Current enrollment or past enrollment in an interventional clinical study in which an investigational gene therapy is/was administered.
* Enrollment in an interventional clinical study in which an investigational small molecule, antibody or antisense oligonucleotide (ASO) treatment or approved small molecule, antibody or ASO therapy for investigational use is administered within 1 month (or 5 half-lives of study agent, whichever is longer) prior to the screening visit.
0 Years
50 Years
ALL
No
Sponsors
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David Bearden
UNKNOWN
University of Rochester
OTHER
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Other Identifiers
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992EP001
Identifier Type: -
Identifier Source: org_study_id
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