STK-001-DS-501 - An Open-Label Extension Study for Patients with Dravet Syndrome who Previously Participated in Studies of STK 001

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Dravet Syndrome
  • Age: Between 2 - 18 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants must be =2.5 years of age
    2. Participants and/or their legal guardians must be willing and able to give informed consent/assent and any authorizations required by local law for participation in the study
    3. Participants and their caregivers must be willing and able (in the Investigator’s opinion) to comply with all protocol requirements
    4. Participants must have completed dosing with STK-001 and the End of Study Visit in Study STK-001-DS-101, with an acceptable safety profile per Investigator judgment
    5. Must have satisfactory compliance with study visits and procedures in Study STK-001- DS-101 per Investigator and Sponsor judgment
    6. Must meet age-appropriate institutional standard practices for IT drug administration procedures
    7. Participants and/or family (or caretaker) must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study
    8. Must have completed Study STK-001-DS-101 within 4 weeks of the start of their participation in Study STK-001-DS-501, unless approved by the Sponsor

You may not be eligible for this study if the following are true:

    1. Participants have met any withdrawal criteria from Study STK-001-DS-101
    2. Currently being treated as maintenance therapy with an antiepileptic drug acting primarily as a sodium channel blocker including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide
    3. Has had clinically significant unstable medical conditions other than epilepsy
    4. has a spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt
    5. Participants has clinically significant (in the judgment of the Investigator) abnormal laboratory values at Screening/Baseline
    6. Participants has a psychiatric or behavioral disorder which, in the opinion of the Investigator, may interfere with the patient’s participation in the study
    7. Participants currently taking, or within 4 weeks prior to Screening/Baseline has taken any anticoagulant (including but not limited to heparins, warfarin and other vitamin K antagonists, dabigatran, rivaroxaban and apixaban), or within 7 days prior to Screening/Baseline, has taken any antiplatelet (including but not limited to aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, ticlopidine. and dipyridamole)
    8. Participants who are female of childbearing potential, or are a fertile male with female partner(s) of childbearing potential, unless willing to ensure that they or their partners use effective contraception throughout the duration of the study and for at least 6 months after their last dose of STK-001
    9. Participants who are female who are lactating or planning pregnancy during the duration of the study and for at least 6 months after their last dose of STK-001
    10. Participants who have any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, may influence the results of the study, or may affect the patient’s ability to participate in the study
    11. Those who have been treated (or is being treated) with an investigational product (other than STK-001) since participating in Study STK-001-DS-101
    12. Participants participating in an observational study, unless approved by the Sponsor



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