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

Conditions

• Developmental and Epileptic Encephalopathy

Eligibility Criteria

Sex

ALL

Age

2 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

Key Dates

Start date

Nov 11, 2024

Status verified

May 2026

Primary completion

Oct 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LP352
  Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.
• Placebo Comparator: Placebo
  Placebo for LP352

Primary Outcome Measure

Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline [ Time Frame: Baseline and up to 15 Weeks ]

Central Contacts

• Email contact via H. Lundbeck A/S
  +45 36301311
  [email protected]

Locations (30)

Find similar trials in Little Rock, AR

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