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LP352 for Epilepsy

Phase 2

Recruiting

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

Study Summary

This trial tests the safety & effectiveness of a new epilepsy treatment over time in people with developmental & epileptic encephalopathies.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Patient Health Questionnaire-9 Total Score and Question 9 Score

Treatment-emergent Adverse Events

Secondary outcome measures

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

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LP352Experimental 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LP352

2022

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Longboard PharmaceuticalsLead Sponsor

2 Previous Clinical Trials

52 Total Patients Enrolled

Dennis J Dlugos, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

1 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

LP352 Clinical Trial Eligibility Overview. Trial Name: NCT05626634 — Phase 2

Developmental Encephalopathy Research Study Groups: LP352

Developmental Encephalopathy Clinical Trial 2023: LP352 Highlights & Side Effects. Trial Name: NCT05626634 — Phase 2

LP352 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626634 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential hazards of LP352 for human health?

"Taking into account the Phase 2 trial status of LP352, our team at Power assigned it a safety rating of 2 due to some data indicating its safety but none suggesting efficacy."

Answered by AI

Who would be the most suitable candidates for participating in this clinical trial?

"For this clinical trial, 50 adults aged 18-65 with early myoclonic encephalopathy can apply. To be eligible they must also fulfil the following requirements: male or non-pregnant/non-lactating female; completed LP352-201 study; diagnosis of Dravet syndrome, Lennox Gastaut Syndrome, or other developmental and epileptic encephalopathies; able to attend visits and follow instructions regarding diaries and drug administration."

Answered by AI

Are participants of this investigation limited to adults aged 20 and older?

"To be considered for this trial, applicants must fall in the age range of 18 to 65. There are 513 trials specifically dedicated to individuals younger than 18 and 1,200 studies tailored towards those over 65 years old."

Answered by AI

Are there any vacancies remaining for individuals to join this clinical trial?

"According to the information posted on clinicaltrials.gov, this medical experiment is still recruiting patients and was first published November 8th 2022 with a recent update on the fifteenth of that same month."

Answered by AI

How many individuals are currently participating in this research?

"Correct. The information published on clinicaltrials.gov suggests that this endeavor, which went live on 8th November 2022, is actively recruiting participants across 24 distinct medical centres with the aim of enrolling a total of 50 patients."

Answered by AI

Are there multiple healthcare facilities conducting this experiment in the metropolitan area?

"Patients can join this clinical trial at any of 24 different locations, including the Wake Forest University School of Medicine in Winston-Salem, University of Utah in Salt Lake City, and Advent Health Orlando."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626634.

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