Clinical trial · Interventional
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-escalation Study to Investigate the Safety, Tolerability, PK, PD, and Exploratory Efficacy of LP352 in Subjects With Developmental and Epileptic Encephalopathies
NCT05364021CI-TRIAL-00082412PACIFICcompletedPhase 1 / Phase 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 safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LP352 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LP352
- description
- Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 60-day maintenance period and a 15-day taper/down titration period.
- interventionNames
- Drug: LP352
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo for LP352
- interventionNames
- Drug: Placebo
Primary outcomes (5)
- measure
- Treatment-emergent Adverse Events
- timeFrame
- Baseline up to Day 75
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Male or non-pregnant, non-lactating female, age 12 to 65 years 2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy 3. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications 4. All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study 5. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed Key Exclusion Criteria: 1. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure 2. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject 3. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior 4. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss 5. 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.