CompletedPhase 1/2

Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

United States52 participantsStarted 2022-03-03

Plain-language summary

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.

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
✓. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
✓. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
✓. All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
✓. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

Exclusion criteria

✕. 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 Day 75

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

Timeframe: Baseline up to Day 75

Patient Health Questionnaire-9 Total Score and Question 9 Score

Timeframe: Baseline up to Day 75

Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Treatment Period

Timeframe: Baseline up to Day 75

Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period

Timeframe: Baseline up to Day 75

Trial details

NCT IDNCT05364021

SponsorLongboard Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-16

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
✓. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
✓. Has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications
✓. All medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study
✓. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed

Exclusion criteria

✕. 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 Day 75

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

Timeframe: Baseline up to Day 75

Patient Health Questionnaire-9 Total Score and Question 9 Score

Timeframe: Baseline up to Day 75

Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Treatment Period

Timeframe: Baseline up to Day 75

Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period

Timeframe: Baseline up to Day 75