Health TrialsbyHealthPanel

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

ConditionDevelopmental and Epileptic Encephalopathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-65
SponsorLongboard Pharmaceuticals

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 24 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms

Presence of developmental plateauing or regression

History of electroencephalogram (EEG) showing generalized slow (<2.5 Hertz [Hz]) spike-and-wave complexes

Disqualifiers

The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.

The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.

The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.

The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: LP352Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline

The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.

Time frame
Baseline and up to 15 Weeks

Secondary outcomes

1

Safety and Tolerability of LP352

Safety and tolerability as measured by incidence and severity of Treatment Emergent Adverse Events (TEAEs), Serious Adverse events (SAEs), AEs leading to discontinuation and clinically significant changes in laboratory parameters (hematology, serum chemistry and Urinalysis), physical examination findings, vital signs, growth parameters (height and weight), 12-lead electrocardiograms (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) responses, and Patient Health Questionnaire-9 (PHQ-9) total score and Question 9 score.

Time frame
Up to 21 Weeks
2

Percentage of participants with ≥ 50% Reduction in countable motor seizures during the Treatment compared to Baseline

Time frame
Baseline and up to 15 Weeks
3

Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline

Time frame
Baseline and up to 15 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Longboard Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now