Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04625101 | Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep | PHASE2 | COMPLETED | 24 | — | — | Apr 26, 2021 | Oct 11, 2022 | Sep 5, 2025 | 15 | United States, Canada +4 |
The ratio of SWI at the end of Week 6 to baseline during the first hour (60 minutes) of NREM sleep based on centralized video-electroencephalograph (EEG) reading using a log base 10 scale. Baseline was defined as the last value measured prior to intake of study treatment on Day 1. SWI was defined as the percentage of seconds with ≥1 spike-wave complex(es) during defined periods of overnight NREM sleep.
| Arm | Type | Description |
|---|---|---|
| NBI-827104 | EXPERIMENTAL | NBI-827104 administered orally for 13 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered orally for 13 weeks. |
| Name | Type | Description |
|---|---|---|
| NBI-827104 | DRUG | Triple T-type calcium channel blocker. |
| Placebo | DRUG | Non-active dosage form. |
Inclusion Criteria: 1. Signed informed consent by the parent(s) or legal representative(s) and, if applicable, assent from developmentally capable pediatric subjects. 2. Diagnosis of EECSWS. 3. Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP). 4. Stable dosage and stable...