Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-escalation Study to Investigate the Safety, Tolerability, PK, PD, and Exploratory Efficacy of LP352 in Subjects With Developmental and Epileptic Encephalopathies
Status: Completed
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Children's Hospital
Little Rock
Arizona
University of Arizona - Health Sciences Center
Tucson
California
Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey
Children's Hospital of Orange County
Orange
University of California San Francisco
San Francisco
Florida
Northwest Florida Clinical Research Group
Gulf Breeze
University of Miami
Miami
Advent Health Orlando
Orlando
Research Institute of Orlando
Orlando
University of South Florida
Tampa
Hawaii
Hawaii Pacific Neuroscience
Honolulu
Idaho
Consultants in Epilepsy and Neurology
Boise
Illinois
Northwestern University Feinberg School of Medicine
Chicago
Maryland
Mid-Atlantic Epilepsy and Sleep Center
Bethesda
Michigan
Spectrum Health
Grand Rapids
Minnesota
Mayo Clinic
Rochester
Missouri
Washington University School of Medicine
St Louis
North Carolina
OnSite Clinical Solutions LLC
Charlotte
Wake Forest University School of Medicine
Winston-salem
New York
Boston Children's Health Physicians LLP
Hawthorne
New York University Langone Hospital - Long Island
Mineola
Northwell Health
New York
Northeast Regional Epilepsy Group
Staten Island
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Oregon
Providence Neurological Specialties-East
Portland
Texas
Austin Epilepsy Care Center
Austin
Child Neurology Consultants of Austin
Austin
Utah
University of Utah
Salt Lake City
Washington
University of Washington Valley Medical Center
Renton
Other Locations
Australia
Monash Children's Hospital, Monash Health
Clayton
Austin Health
Heidelberg
Royal Brisbane Women's Hospital
Herston
Alfred Health
Melbourne
Queensland Children's Hospital
South Brisbane
Time Frame
Start Date: 2022-03-03
Completion Date: 2023-11-20
Participants
Target number of participants: 52
Treatments
Experimental: LP352
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.
Placebo_comparator: Placebo
Placebo for LP352
Related Therapeutic Areas
Sponsors
Leads: Longboard Pharmaceuticals