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LP352 for Developmental Encephalopathy (PACIFIC Trial)

Phase 1 & 2
Waitlist Available
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 day 75
Awards & highlights

PACIFIC Trial Summary

This trial will study the effects of a new drug, LP352, on adults and adolescents with developmental and epileptic encephalopathies. The goal is to see if it is safe and effective.

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

PACIFIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 75
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 75 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
Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period
+2 more
Secondary outcome measures
Correlation of Plasma Concentration with Incidence of Treatment-emergent Adverse Events
Correlation of Plasma Concentration with Seizure Frequency
Modeled Estimate of Average Plasma Concentration
+3 more

PACIFIC Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LP352Experimental Treatment1 Intervention
Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 60-day maintenance period and a 15-day taper/down titration period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo for LP352
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LP352
2022
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Longboard PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
Dennis J Dlugos, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

LP352 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05364021 — Phase 1 & 2
Developmental Encephalopathy Research Study Groups: LP352, Placebo
Developmental Encephalopathy Clinical Trial 2023: LP352 Highlights & Side Effects. Trial Name: NCT05364021 — Phase 1 & 2
LP352 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364021 — Phase 1 & 2

Frequently Asked Questions

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

Are there any stipulations for who can and cannot be a part of this research?

"This global medical trial is looking for 50 participants that suffer from lennox gastaut syndrome and are aged between 12 and 65. It's important to meet the following requirements: The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed, 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-se"

Answered by AI

If a patient is over the age of 70, can they still participate in this research project?

"The age limit for this particular study is 12 to 65. However, if you search the clinical trials database for studies involving patients under 18, there are 525 results. For those over 65, there are 1251 trials."

Answered by AI

How many patients are in this clinical trial currently?

"Yes, that is accurate. The clinicaltrials.gov website says that this research is open for recruitment and was originally posted on March 3rd, 2022. The most recent update was on September 9th, 2022. Up to 50 patients can participate at 28 different research sites."

Answered by AI

On how many different websites is this trial being run today?

"So far, 28 patients have been recruited for this clinical trial with more potential enrollees at locations like Boston Children's Health Physicians LLP in Hawthorne, Spectrum Health in Grand Rapids, OnSite Clinical Solutions LLC in Charlotte, and 25 other sites."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
< 18
What site did they apply to?
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
2022. "Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05364021.
All > Honolulu
~17 spots leftby Apr 2025
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