Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05301894
Eligibility Criteria:
Key Inclusion Criteria:
For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:
* Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.
For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:
* Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP).
Key Exclusion Criteria:
For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:
* 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.
For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:
* Body weight \<15 kg at Day 1.
* Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
* Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (for example, neonatal strokes) have to be stable for at least 1 year prior to screening.
* Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
* 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 screening or plans to use such an investigational drug (other than NBI-827104) during the study.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT05301894
Study Brief:
Protocol Section:
NCT05301894