A Study to Investigate how effective, safe and tolerable the drug NBI-921352 is when used with anti-seizure medications in adults with focal onset seizures
- Conditions
- Focal Onset Seizures (FOS)MedDRA version: 21.1Level: LLTClassification code 10016843Term: Focal seizuresSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-001433-39-BE
- Lead Sponsor
- eurocrine Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Subjects must meet all of the following inclusion criteria:
• Capable of providing consent and has completed the written informed consent.
• Male or female, 18 to 65 years of age, inclusive, with a body mass index <40 kg/m2.
• Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening. Diagnosis must be confirmed using the central adjudication process.
• Documented seizure frequency in the baseline seizure diary
• History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
• Treatment with at least 1 but not more than 4 ASMs for at least 1 month before screening, during the baseline seizure diary data collection, and throughout the duration of the study.
• Female subjects of childbearing potential must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study treatment, whichever is longer.
• Be able to keep accurate seizure diaries
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Subjects will be excluded from the study if they meet any of the following criteria:
•History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
•Presence or previous history of developmental and/or epileptic encephalopathy.
•Presence of seizure types other than FOS.
•History of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
•Status epilepticus within the last 12 months before enrollment.
•Any suicidal behavior or suicidal ideation of type 4 or type 5 in the 2 years before screening, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
•History or presence of any significant medical or surgical condition, lab value, or concomitant medication that would place the subject at increased risk as determined by the investigator.
•A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate.
•Currently taking disallowed medications listed in Section 7.1.1 or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study.
•Past use of vigabatrin without stable visual fields tested twice in the 12 months after the last dose of vigabatrin.
•Require use of rescue medication more than once per week.
•Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
•An implanted responsive neurostimulator system (RNS).
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