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

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

First listed

Apr 3, 2025

Start date

Feb 12, 2025

Status verified

Aug 2026

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 (20)

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