Clinical trial NCT06149663: Intermediate-Size Expanded Access Protocol (EAP) for LP352
Official title: Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Dravet Syndrome
Lennox Gastaut Syndrome
Developmental and Epileptic Encephalopathies
Keywords: CDKL5 deficiency disorder
developmental and epileptic encephalopathy
Dravet Syndrome
epilepsy
Lennox Gastaut Syndrome
treatment resistant epilepsy
tuberous sclerosis complex
Lead sponsor: Longboard Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-29
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.


Eligibility criteria: Inclusion Criteria:

1. Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (\<18 years of age) as required by local regulations.
2. Participant with DEE who has successfully completed an LP352 Clinical Trial.
3. Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
4. Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.

Exclusion Criteria:

1. Participant was discontinued from an LP352 Clinical Trial for any reason.
2. Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: San Francisco
country: United States
facility: University of California Benioff Childrens Hospital
state: California
city: Aurora
country: United States
facility: Colorados Childrens Hospital
state: Colorado
city: Gulf Breeze
country: United States
facility: Northwest Florida Clinical Research Group
state: Florida
city: Orlando
country: United States
facility: Research Institute of Orlando
state: Florida
city: Tampa
country: United States
facility: University of Southern Florida
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Medicine Feinberg School of Medicine
state: Illinois
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: New York University (NYU)
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Brain & Spine
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Austin
country: United States
facility: Children's Neuro Consultants of Austin
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Heidelberg
country: Australia
facility: Austin Hospital, Heidelberg
state: Melbourne
city: South Brisbane
country: Australia
facility: Children's Health Queensland Hospital and Health Service,
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
Study officials:
References: