Phase
Condition
Dravet Syndrome
Unverricht-lundborg Syndrome
Seizure Disorders (Pediatric)
Treatment
STK-001
Clinical Study ID
Ages > 30 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Completed dosing with STK-001 and the End of Study Visit in Study STK-001-DS-101 orStudy STK-001-DS-102, with an acceptable safety profile per Investigator judgment.
- Had satisfactory compliance with study visits and procedures in Study STK-001-DS-101or Study STK-001-DS-102 per Investigator and Sponsor judgment.
- Completed Study STK-001-DS-101 or STK-001-DS-102 within 4 weeks of the start of theirparticipation in Study STK-001-DS-501 unless approved by sponsor.
Exclusion
Exclusion Criteria:
- Met any withdrawal criteria from Study STK-001-DS-101 or STK-001-DS-102.
- Currently treated with an antiepileptic drug (AED) acting primarily as a sodiumchannel blocker, as maintenance therapy, including phenytoin, carbamazepine,oxcarbazepine, lamotrigine, lacosamide, rufinamide or cenobamate.
- Clinically significant unstable medical conditions other than epilepsy.
- Clinically relevant symptoms or a clinically significant illness (in the judgment ofthe Investigator) at Screening or prior to dosing on Day 1, other than epilepsy.
- Spinal deformity or other condition that may alter the free flow of CSF or has animplanted CSF drainage shunt.
- Treated (or is being treated) with an investigational product (other than STK-001)since participating in Study STK-001-DS-101 or STK-001-DS-102.
- Participating in an observational study, they are excluded unless approved by theSponsor.
Study Design
Study Description
Connect with a study center
University of California San Francisco Medical Center
San Francisco, California 94158
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Nicklaus Children's Hospital
Miami, Florida 33155
United StatesSite Not Available
Florida Hospital for Children
Orlando, Florida 32803
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
University of Iowa Children's Hospital
Iowa City, Iowa 52242
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Michigan Medicine
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
NYU Comprehensive Epilepsy Center
New York, New York 10016
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UT LeBonheur Pediatric Specialists, Inc.
Memphis, Tennessee 38103
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington 98405
United StatesSite Not Available
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