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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to day 75
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 75
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 moreSecondary 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 morePACIFIC 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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, or other similar conditions that involve developmental delays and epilepsy.I'm sorry, I cannot provide a summary for this criterion as it is incomplete. Please provide more information.You are male or non-pregnant, non-lactating female, age 12 to 65 years.You have at least 4 seizures per 4-week period while taking 1 to 4 anti-seizure medications.You are willing to attend study visits, complete the diary and take study drug as instructed.You are currently taking drugs for weight loss such as anorectic agents, monoamine oxidase inhibitors, or serotonin agonists/antagonists like fenfluramine, atomoxetine, and vortioxetine.You have had moderate or severe depression, anorexia nervosa, or bulimia recently, or are at risk of suicidal behavior.You have a medical condition such as glaucoma, kidney or liver disease or any other condition that could affect your participation in the study or put you at risk.
Research Study Groups:
This trial has the following groups:- Group 1: LP352
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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