CompletedPhase 2

Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy

United States41 participantsStarted 2022-11-08

Plain-language summary

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.

Who can participate

Age range12 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201
✓. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
✓. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

Exclusion criteria

✕. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug
✕. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
✕. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
✕. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
✕. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
✕. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol

What they're measuring

Treatment-emergent Adverse Events

Timeframe: Baseline up to Week 52

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

Timeframe: Baseline up to Week 52

Patient Health Questionnaire-9 Total Score and Question 9 Score

Timeframe: Baseline up to Week 52

Trial details

NCT IDNCT05626634

SponsorLongboard Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Developmental and Epileptic Encephalopathy trials

Who can participate

Age range12 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201
✓. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
✓. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

Exclusion criteria

✕. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug
✕. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
✕. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
✕. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
✕. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
✕. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol