A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathies
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathies
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.
Inclusion Criteria:
Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:
Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:
The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic.
The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening.
The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
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 must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative.
Exclusion Criteria:
Atlanta, Georgia 30329, United States
Livingston, New Jersey 07039-5817, United States
Morristown, New Jersey 07960, United States
Portland, Oregon 97239-3098, United States
Austin, Texas 78731-3157, United States
Fort Worth, Texas 76104, United States
Houston, Texas 77030-1517, United States
Porto Alegre, Rio Grande do Sul 90035-001, Brazil
Ribeirão Preto, São Paulo 14051-140, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Vancouver, British Columbia V6H 3V4, Canada
Shenzhen Shi, Guangdong 518026, China
Toulouse, Occitanie 31059, France
Pavia, Lombardy 27100, Italy
Verona, 37126, Italy
Saitama-shi, Saitama 330-8777, Japan
Shizuoka, Shizuoka 420-0953, Japan
Mibu-Machi, Tochigi 321-0293, Japan
Kodaira-shi, Tokyo 187-8551, Japan
Mexico City, Mexico City 04530, Mexico
Belgrade, Beograd 112112, Serbia
Espluges de Llobregat, Barcelona 08950, Spain
Valencia, 46026, Spain
Newcastle upon Tyne, North East NE1 4LP, United Kingdom
Southampton, South East SO16 6YD, United Kingdom
Birmingham, West Midlands B15 2WB, United Kingdom
Glasgow, G51 4TF, United Kingdom