Open-label extesnion study of soticlestat in Dravet and Lennox-Gastaut Syndromes

You may be able to join if

• 01. Subject must have: been previously enrolled in a phase 3 soticlestat clinical study; received at least 12 weeks of treatment (combined Titration and Maintenance Periods) with the study drug in the antecedent study and not have a serious or severe AE that, in the investigator’s or sponsor’s opinion, was related to the study drug and would make it unsafe for the patient to continue receiving the study drug.
• 02. In the opinion of the investigator, the subject has the potential to benefit from the administration of soticlestat.
• "03. In the opinion of the investigator, the subject and/or the subject’s parent or legal guardian or caregiver is capable of understanding and complying with protocol requirements including completion of appropriate assessments, maintaining an accurate and complete daily seizure diary, and taking study drug for the duration of the study. If the subject is living in a residential facility, a minimally possible number of staff member(s) at the facility who are the subject’s primary caretaker(s) may be identified as caregivers who (per investigator’s judgment) are capable of complying with protocol requirements as indicated above."
• "04. The subject or the subject’s parent or legal guardian is willing and able to read, understand, and sign and date an informed consent form (ICF), assent form (if applicable), and any required privacy authorization before the initiation of any study procedures. In the opinion of the investigator, the subject and/or the subject’s parent or legal guardian or caregiver is capable of understanding and complying with protocol requirements including completion of appropriate assessments, maintaining an accurate and complete daily seizure diary, and taking study drug for the duration of the study. If the subject is living in a residential facility, a minimally possible number of staff member(s) at the facility who are the subject’s primary caretaker(s) may be identified as caregivers who (per investigator’s judgment) are capable of complying with protocol requirements as indicated above."
• "05. Female subjects of childbearing potential (defined as first menarche) must have a negative pregnancy test and agree to use an effective (not applicable for Germany) or highly effective method of birth control during the study and for 30 days following the last dose of study drug. Effective contraceptive methods include the following (not applicable for Germany): • Double-barrier method (contraceptive sponge, diaphragm, or cervical cap with spermicidal jellies or creams PLUS male condom). • Progestogen-only hormonal contraception, where inhibition of ovulation is not the primary mode of action, PLUS condom with or without spermicide. Highly effective contraceptive methods include the following: • Nonhormonal methods: – Intrauterine device. – Bilateral tubal occlusion. – Vasectomized partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success). Sexual abstinence: Sexual abstinence may be considered as a method only if defined as refraining from heterosexual intercourse and determined to be the usual lifestyle before entering the study with reliability of abstinence for the duration of the study participation and for 30 days after last dose of study drug. • Hormonal methods: – Combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation, initiated at least 3 months before the first dose of study drug OR combined with a barrier method (male condom, female condom or diaphragm) if for shorter duration until she has been on contraceptive for 3 months. – Progestogen-only hormonal contraception associated with inhibition of ovulation, initiated at least 3 months before the first dose of study drug OR combined with a barrier method (male condom, female condom or diaphragm) if shorter until she has been on the contraceptive for 3 months."