LP352 for Developmental and Epileptic Encephalopathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Developmental and Epileptic Encephalopathy+2 MoreLP352 - Drug
Eligibility
12 - 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Developmental and Epileptic Encephalopathy
  • Dravet Syndrome
  • Lennox Gastaut Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Week 3 to Week 50

Baseline to Week 50
Change in Mean Drop Seizure Frequency from Baseline to End of Treatment Period
LGS: Percentage Change from Baseline in Frequency of Observed Drop Seizures Over Treatment Period
LGS: Percentage Change from Baseline in the Frequency of Observed Drop Seizures Over the Treatment Period
Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period
Percent Change from Baseline in the Number of Episodes of Status Epilepticus During the Treatment Period
Percent Reduction in Individual Seizure Type During the Treatment Period
Percent of Subjects with Countable Motor Seizure-free Days During the Treatment Period
Percentage Change from Baseline in Non-motor and Difficult to Count Seizures
Proportion of Subjects Requiring Rescue Medication During the Treatment Period
Proportion of Subjects with > 50% Reduction in Total Seizures During the Treatment Period
Week 52
Columbia-Suicide Severity Rating Scale (C-SSRS) Response
Patient Health Questionnaire-9 Total Score and Question 9 Score
Treatment-emergent Adverse Events
Week 50
Percentage Change from Baseline in Frequency of Observed Seizures During the Maintenance Period

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

LP352
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: LP352 · No Placebo Group · Phase 2

LP352
Drug
Experimental Group · 1 Intervention: LP352 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 3 to week 50

Who is running the clinical trial?

Longboard PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Developmental and Epileptic Encephalopathy
50 Patients Enrolled for Developmental and Epileptic Encephalopathy
Dennis J Dlugos, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Developmental and Epileptic Encephalopathy
50 Patients Enrolled for Developmental and Epileptic Encephalopathy

Eligibility Criteria

Age 12 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or non-pregnant, non-lactating female between the ages of 12 and 65 who has successfully concluded the LP352-201 study.
You have been diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathies.
The patient/parent/caregiver is capable and available to participate in study meetings, record data and take the medication as directed.