Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental and epileptic encephalopathy who completed Study LP352-201.
The study consists of a Screening Period (Day -1) and a 50-week open-label Treatment Period that includes a 15-day Up-titration Period (during which time subjects will titrate up to their highest tolerated doses) and an open-label Maintenance Period (48 weeks). The Treatment Period will be followed by a Down-titration/Taper Period (up to 15 days) and Follow-up Period (14 days after completion of down-titration). The starting dose of up-titration will be 6 mg TID. The target final maintenance doses are 6 mg TID, 9 mg TID, and 12 mg TID after a 15-day up-titration period, if tolerated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP352, bexicaserin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP352, bexicaserin | Drug | LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events | Incidence and severity of treatment-emergent adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs | Baseline up to Week 52 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) Response | Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior | Baseline up to Week 52 |
| Patient Health Questionnaire-9 Total Score and Question 9 Score | Severity Rating Scale: 0 - 27; higher scores indicate greater severity of depressive disorder | Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period | Baseline Used for Seizure Frequency = Baseline from Study LP352-201 and Baseline from Study LP352-202 | Baseline to Week 50 |
| Proportion of Subjects with > 50% Reduction in Total Seizures During the Treatment Period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dennis J Dlugos, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Rancho Los Amigos National Rehabilitation Center (RLANRC) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to Week 50 |
| Percent Reduction in Individual Seizure Type During the Treatment Period | Baseline to Week 50 |
| Proportion of Subjects Requiring Rescue Medication During the Treatment Period | Baseline to Week 50 |
| Percent Change from Baseline in the Number of Episodes of Status Epilepticus During the Treatment Period | Baseline to Week 50 |
| Percent of Subjects with Countable Motor Seizure-free Days During the Treatment Period | Baseline to Week 50 |
| Percentage Change from Baseline in Non-motor and Difficult to Count Seizures | Baseline to Week 50 |
| LGS: Percentage Change from Baseline in the Frequency of Observed Drop Seizures Over the Treatment Period | Baseline to Week 50 |
| Downey |
| California |
| 90242 |
| United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Northwest Florida Clinical Research Group | Gulf Breeze | Florida | 32561 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Advent Health Orlando | Orlando | Florida | 32803 | United States |
| Research Institute of Orlando | Orlando | Florida | 32806 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Boston Children's Health Physicians LLP | Hawthorne | New York | 10532 | United States |
| Northwell Health | New York | New York | 10075 | United States |
| Northeast Regional Epilepsy Group | Staten Island | New York | 10305 | United States |
| OnSite Clinical Solutions LLC | Charlotte | North Carolina | 98277 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Providence Neurological Specialties-East | Portland | Oregon | 97213 | United States |
| Child Neurology Consultants of Austin | Austin | Texas | 78757 | United States |
| Austin Epilepsy Care Center | Austin | Texas | 78758 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Washington Valley Medical Center | Renton | Washington | 98055 | United States |
| Queensland Children's Hospital | South Brisbane | Queensland | 4101 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| D065768 | Lennox Gastaut Syndrome |
| C564064 | CDKL5 deficiency disorder |
| D004827 | Epilepsy |
| D014402 | Tuberous Sclerosis |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D065703 | Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided