A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

Description

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Conditions

Developmental and Epileptic Encephalopathy

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Study Overview

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Study Details

Study overview

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

Condition
Developmental and Epileptic Encephalopathy
Intervention / Treatment

-

Contacts and Locations

Little Rock

Site Number - USA19, Little Rock, Arkansas, United States, 72202

La Jolla

Site Number - USA29, La Jolla, California, United States, 92037

Los Angeles

Site Number - USA26, Los Angeles, California, United States, 90027

Los Angeles

Site Number - USA18, Los Angeles, California, United States, 90095

Palo Alto

Site Number - USA24, Palo Alto, California, United States, 94304

San Francisco

Site Number - USA28, San Francisco, California, United States, 94904

Aurora

Site Number - USA17, Aurora, Colorado, United States, 80045

Gulf Breeze

Site Number - USA02, Gulf Breeze, Florida, United States, 32561

Miami

Site Number - USA37, Miami, Florida, United States, 33155

Orlando

Site Number - USA05, Orlando, Florida, United States, 32806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
  • * Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
  • * Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
  • * The participant or legal representative must be willing and able to provide written informed consent
  • * The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
  • * The participant is receiving exclusionary medications.
  • * Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% Delta-9-tetrahydrocannabinol (THC).
  • * The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia) pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
  • * The participant is unable or unwilling to comply with any of the study requirements or timelines.

Ages Eligible for Study

2 Years to 66 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Longboard Pharmaceuticals,

Study Record Dates

2027-12