Clinical trial

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

Name

LP352-202

Description

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.

Trial arms

Trial start

2022-11-08

Estimated PCD

2024-10-01

Trial end

2024-10-01

Status

Recruiting

Phase

Early phase I

Treatment

LP352

LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube

Arms:

LP352

Size

Primary endpoint

Treatment-emergent Adverse Events

Baseline up to Week 52

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

Baseline up to Week 52

Patient Health Questionnaire-9 Total Score and Question 9 Score

Baseline up to Week 52

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-12-20

1 organization

1 product

3 indications

Organization

Longboard Pharmaceuticals

Product

LP352

Indication

Developmental and Epileptic Encephalopathy

Indication

Dravet syndrome

Indication

Lennox-Gastaut Syndrome