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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Longboard Pharmaceuticals
Study ID
NCT06908226
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Developmental and Epileptic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
2 Years - 66 Years
Healthy Volunteers
Not accepted

Interventions

  • LP352 — DRUG
    LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube.

Study Details

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.

Key Dates

Start date
Feb 12, 2025
Status verified
Dec 2025
Primary completion
Nov 11, 2027
Completion
Dec 17, 2027

Study Design

Enrollment
324 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LP352
    Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 1 - Visit 3), followed by maintenance period (Visit 4 - Visit 14) and then taper/down titration period (Visit 15 - Visit 17).

Primary Outcome Measure

Number of participants reporting Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) and AEs leading to discontinuation [ Time Frame: Up to 61 Weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
Arkansas Children's Hospital - PINLittle RockArkansas72202-3500-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
NW FL Clinical Research Group, LLCGulf BreezeFlorida32561-4458-
Research Institute of Orlando LLCOrlandoFlorida32806-5411-
Pediatric Epilepsy and Neurology SpecialistsTampaFlorida33609-4181-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-1809-
Institute of Neurology and Neurosurgery at Saint Barnabas, LLCLivingstonNew Jersey07039-5817-
Northeast Regional Epilepsy Group - Morristown - 310 Madison AveMorristownNew Jersey07960-
The University of Texas Medical School at HoustonHoustonTexas77030-3000-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital - PIN· Little Rock, ARDavid Geffen School of Medicine at UCLA· Los Angeles, CANW FL Clinical Research Group, LLC· Gulf Breeze, FLResearch Institute of Orlando LLC· Orlando, FLPediatric Epilepsy and Neurology Specialists· Tampa, FLMid-Atlantic Epilepsy and Sleep Center· Bethesda, MD

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