Phase
Condition
Seizure Disorders (Pediatric)
Dravet Syndrome
Unverricht-lundborg Syndrome
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 oftheir participation 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
University of California San Francisco Medical Center
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106 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
Nicklaus Children's Hospital
Miami 4164138, Florida 4155751 33155
United StatesSite Not Available
Florida Hospital for Children
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
University of Iowa Children's Hospital
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Children's Hospital
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Michigan Medicine
Ann Arbor, Michigan 48109
United StatesSite Not Available
Michigan Medicine
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
NYU Comprehensive Epilepsy Center
New York, New York 10016
United StatesSite Not Available
NYU Comprehensive Epilepsy Center
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
UT LeBonheur Pediatric Specialists, Inc.
Memphis, Tennessee 38103
United StatesSite Not Available
UT LeBonheur Pediatric Specialists, Inc.
Memphis 4641239, Tennessee 4662168 38103
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 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
Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available
MultiCare Health System Institute for Research and Innovation
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

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