Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS) MedDRA version: 20.0 Level: PT Classification code 10077380 Term: Epileptic encephalopathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Neurocrine Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written or oral pediatric assent from the subject deemed capable of providing assent and written informed consent from the subject’s parent(s) or legal guardian(s) in accordance with the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and according to local laws and regulations. Informed consent/assent may be done remotely, if allowed per site and remote consenting procedures are in place. 2. Completed 12 weeks of treatment (3 weeks titration and 9 weeks maintenance) in Study NBI-827104-CSWS2010. 3. Subjects of childbearing potential must agree to use highly effective birth control methods consistently while participating in the study until 90 days after the last dose of the study treatment. A female subject of childbearing potential is defined as a subject who has had her first menstrual cycle (ie, menarche). A male subject of childbearing potential is defined as a subject who has reached spermarche. 4. Willing to comply with all study procedures and restrictions. Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding. 2. Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit. 3. Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before Day 1 or plans to use such an investigational drug (other than NBI-827104) during the study. 4. It is anticipated that the subject will require treatment with at least 1 of the prohibited concomitant medications or other restrictions during the specified study time frame. 5. Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance. 6. The subject or the subject’s parent(s)/caregiver(s) are, in the investigator’s opinion, unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of NBI-827104 in pediatric subjects with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS) when administered for up to 106 weeks ;Secondary Objective: • To investigate the effect of NBI-827104 on the overnight epileptiform video-electroencephalogram (video-EEG) activity in pediatric subjects with EECSWS. • To investigate the long-term effect of NBI-827104 on the symptoms of EECSWS, including sleep and cognition, in pediatric subjects. ;Primary end point(s): The occurrence of serious Treatment-emergent adverse event (TEAEs), TEAEs leading to discontinuation of study treatment, and fatal TEAEs ;Timepoint(s) of evaluation of this end point: 110 Weeks for subjects who enrol directly and 114 Weeks for subjects who do not enrol directly. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Ratio of SWI at Week 26 compared to baseline during the first hour of NREM sleep, based on centralized video-EEG reading. • Change from baseline in CGI-S score at Week 26 • CGI-C and Caregiver GI-C scores at Week 26. ;Timepoint(s) of evaluation of this end point: Week 26 | — |
Countries
Canada, Denmark, France, Germany, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactRegulatory Unit
Accelsiors CRO and Consultancy Services Ltd.
Outcome results
None listed