A long-duration study to assess the safety and effectiveness of NBI-827104 in children with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep.
- Conditions
- Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS)MedDRA version: 20.0Level: PTClassification code 10077380Term: Epileptic encephalopathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-006788-11-DK
- Lead Sponsor
- eurocrine Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
1. Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.
2. For subjects who did not participate in Study NBI-827104-CSWS2010, they must have a diagnosis of EECSWS including confirmation by the Diagnosis Confirmation Panel.
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
1. Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
2. 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.
3. 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.
4. For subjects who did not participate in NBI-827104-CSWS2010, they must meet the above exclusion criteria in addition to the following (4-6): presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (eg, neonatal strokes) have to be stable for at least 1 year prior to screening.
5. Body weight = 15 kg at Day 1
6. Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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);Secondary Objective: Not applicable;Primary end point(s): The occurrence of serious Treatment-emergent adverse event (TEAEs);Timepoint(s) of evaluation of this end point: Up to 242 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable