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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05066217 | An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome | PHASE3 | RECRUITING | 260 | — | — | Apr 9, 2025 | Nov 1, 2029 | Apr 15, 2026 | 20 | United States |
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive their first dose of study drug following randomization. |
| Double-blind clemizole HCl | EXPERIMENTAL | Participants will receive their first dose of study drug following randomization. |
| Open-label clemizole HCl | EXPERIMENTAL | Eligible participants who complete the DB Period will have the option to continue in the OLE Period, during which they will receive clemizole HCl for up to 3 years. |
| Name | Type | Description |
|---|---|---|
| Clemizole HCl | DRUG | Clemizole HCl will be administered as an oral solution. |
| Placebo | DRUG | Placebo will be administered as an oral solution. |
Key Inclusion Criteria: 1. Males or females, ages ≥2 to ≤55 years, at the time of Screening. 2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent. 3. Diagnosis of LGS, including: * Evidence of at least one type of countable major m...