A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults with Developmental and Epileptic Encephalopathy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514974-39-00

Acronym

LP352-303

Enrollment

175

Registered

2025-06-17

Start date

2025-10-10

Completion date

Unknown

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental and Epileptic Encephalopathies (DEEs)

Brief summary

1. Incidence and severity of TEAEs, including SAEs and AEs leading to discontinuation, 2. Safety laboratory parameters, 3. Physical examination findings, 4. Vital signs, 5. Growth parameters (height and weight), 6. 12-lead ECGs, 7. C-SSRS responses, 8. PHQ-9 total score and Question 9 score

Detailed description

1. Frequency percent change in countable motor seizures during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary, 2. 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary, 3. Frequency percent change in countable motor seizures during Maintenance (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary

Interventions

DRUGLP352 (bexicaserin) Placebo Oral Solution

DRUGBexicaserin

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence and severity of TEAEs, including SAEs and AEs leading to discontinuation, 2. Safety laboratory parameters, 3. Physical examination findings, 4. Vital signs, 5. Growth parameters (height and weight), 6. 12-lead ECGs, 7. C-SSRS responses, 8. PHQ-9 total score and Question 9 score	—

Secondary

Measure	Time frame
1. Frequency percent change in countable motor seizures during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary, 2. 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Treatment (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary, 3. Frequency percent change in countable motor seizures during Maintenance (28-day average) compared to Baseline (28-day average) as assessed by seizure eDiary	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Italy, Latvia, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026