A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
Recruiting
Phase 3
Interventional Study
Developmental and Epileptic Encephalopathy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 320 (estimated)
- Sponsor
- Longboard Pharmaceuticals · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:
* Onset of seizures at ≤8 years old
* History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, …
Contacts