Clinical trial · Interventional
Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
A Phase 2, Multicenter, Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Who Completed Study LP352-201 and Are Candidates for Continuous Treatment for Up to 52 Weeks
NCT05626634CI-TRIAL-00098310completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Developmental and Epileptic Encephalopathy | — | UNRESOLVED | — |
| Dravet Syndrome | — | UNRESOLVED | — |
| Lennox-Gastaut Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LP352, bexicaserin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LP352, bexicaserin
- description
- Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 48-week maintenance period and a 15-day taper/down titration period.
- interventionNames
- Drug: LP352, bexicaserin
Primary outcomes (3)
- measure
- Treatment-emergent Adverse Events
- timeFrame
- Baseline up to Week 52
- description
- Incidence and severity of treatment-emergent adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs
- measure
- Columbia-Suicide Severity Rating Scale (C-SSRS) Response
- timeFrame
- Baseline up to Week 52
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201 2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy 3. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed Exclusion Criteria: 1. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug 2. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure 3. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject 4. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior 5. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss 6. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
References
Publications (0)
Data not yet available
No reference posted for this study.