Open-label extesnion study of soticlestat in Dravet and Lennox-Gastaut Syndromes
- Conditions
- Dravet and Lennox-Gastaut SyndromesMedDRA version: 20.0Level: LLTClassification code: 10073682Term: Dravet syndrome Class: 10010331MedDRA version: 20.1Level: PTClassification code: 10048816Term: Lennox-Gastaut syndrome Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-502802-34-00
- Lead Sponsor
- Takeda Development Center Americas Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 377
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 le
01. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted., 02. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 ms confirmed with a repeat ECG using manual measurement of QTcF. Clinically significant ECG abnormalities should be discussed with the medical monitor., 03. Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last dose of study drug., 04. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Subjects who have positive answers on item numbers 4 or 5 on the C SSRS before dosing are excluded. This scale will only be administered to subjects aged =6 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method