What side effects are associated with this type of intervention?

Common treatments for developmental and epileptic encephalopathies include antiepileptic drugs such as valproate, lamotrigine, and levetiracetam. Valproate can cause nausea, somnolence, tremor, dizziness, weight gain, and hair loss, and is contraindicated in pregnancy due to teratogenicity. Lamotrigine may lead to skin rashes, including severe reactions like Stevens-Johnson syndrome. Levetiracetam is associated with behavioral changes such as irritability and aggression. These treatments aim to control seizures but come with a range of potential side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for developmental and epileptic encephalopathies, focusing on novel therapeutic agents targeting specific pathways involved in epilepsy. One notable example is cannabidiol (CBD), which has shown efficacy in reducing seizure frequency in conditions like Dravet syndrome. Other treatments include antiepileptic drugs such as valproate and lamotrigine, which have been used to manage generalized and focal epilepsy, respectively. These treatments aim to modulate neural activity and reduce seizure occurrences, similar to the investigational agent LP352.

What other types of research exist?

Promising novel alternatives to LP352 for developmental encephalopathy patients include: 1) Gene therapy approaches targeting specific genetic mutations associated with developmental encephalopathies, 2) Antisense oligonucleotides (ASOs) that modulate gene expression, 3) Small molecule modulators of neurogenesis and synaptic function, and 4) Emerging pharmacotherapies such as trofinetide and glatiramer acetate, which have shown potential in related neurodevelopmental disorders like Rett syndrome.

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LP352 for Epilepsy

Phase 2

Waitlist Available

Led By Dennis J Dlugos, MD

Research Sponsored by Longboard Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of the medication LP352 in patients with specific types of epilepsy. These patients have already participated in a previous study of this medication. The study increases the dose to find the best amount and then maintains it to see if it helps control seizures.

Who is the study for?

This trial is for individuals aged 12-65 with developmental and epileptic encephalopathies like Dravet or Lennox-Gastaut syndrome, who completed a prior LP352 study. They must be able to attend visits, keep a diary, and take the drug as instructed. Exclusions include certain heart diseases, glaucoma, severe depression or eating disorders.

What is being tested?

The study tests the long-term safety and effectiveness of LP352 as an additional treatment for epilepsy syndromes in patients who previously participated in Study LP352-201. It's an open-label trial where everyone receives the drug.

What are the potential side effects?

While specific side effects of LP352 are not listed here, common ones may include dizziness, fatigue, gastrointestinal issues or changes in mood or behavior due to its action on the central nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Columbia-Suicide Severity Rating Scale (C-SSRS) Response

Patient Health Questionnaire-9 Total Score and Question 9 Score

Treatment-emergent Adverse Events

Secondary study objectives

Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LP352, bexicaserinExperimental Treatment1 Intervention

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for developmental encephalopathy, such as valproate, lamotrigine, and levetiracetam, work through various mechanisms to control seizures. Valproate increases GABA levels to inhibit neuronal firing, lamotrigine stabilizes neuronal membranes by inhibiting voltage-gated sodium channels, and levetiracetam modulates neurotransmitter release by binding to the synaptic vesicle protein SV2A. These mechanisms are crucial for managing seizures in developmental encephalopathy patients, as uncontrolled seizures can severely affect cognitive and developmental outcomes.

Therapeutic strategies to avoid long-term adverse outcomes of neonatal antiepileptic drug exposure.