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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06719141




Registration number
NCT06719141
Ethics application status
Date submitted
2/12/2024
Date registered
5/12/2024
Date last updated
14/01/2025

Titles & IDs
Public title
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
Scientific title
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
Secondary ID [1] 0 0
2024-516412-17-00
Secondary ID [2] 0 0
LP352-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental and Epileptic Encephalopathy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LP352
Treatment: Drugs - Placebo

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


Treatment: Drugs: LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube

Treatment: Drugs: Placebo
Participants will be administered with matching placebo orally or through G-tube/ PEG tube.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
Timepoint [1] 0 0
Baseline and up to 15 Weeks
Secondary outcome [1] 0 0
Safety and Tolerability of LP352
Timepoint [1] 0 0
Up to 21 Weeks
Secondary outcome [2] 0 0
Percentage of participants with = 50% Reduction in countable motor seizures during the Treatment compared to Baseline
Timepoint [2] 0 0
Baseline and up to 15 Weeks
Secondary outcome [3] 0 0
Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline
Timepoint [3] 0 0
Baseline and up to 15 Weeks

Eligibility
Key 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, 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
* Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:

* Does not meet criteria for LGS
* Onset of seizures at =5 years old
* Presence of developmental plateauing or regression
* History of multiple seizure types
* History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)
* 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.
Minimum age
2 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* The participant is receiving exclusionary medications.
* The participant has used of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains =50% Delta-9-tetrahydrocannabinol (THC).
* The participant has unstable, clinically significant neurologic (other than the disease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
* The participant is unable or unwilling to comply with any of the study requirements or timelines.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site Number - AUS07 - Randwick
Recruitment hospital [2] 0 0
Site Number - AUS08 - Randwick
Recruitment hospital [3] 0 0
Site Number - AUS04 - Herston
Recruitment hospital [4] 0 0
Site Number - AUS05 - South Brisbane
Recruitment hospital [5] 0 0
Site Number - AUS02 - Heidelberg
Recruitment hospital [6] 0 0
Site Number - AUS03 - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Longboard Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06719141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Longboard Study Contact
Address 0 0
Country 0 0
Phone 0 0
858-999-8858
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06719141