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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06908226




Registration number
NCT06908226
Ethics application status
Date submitted
6/03/2025
Date registered
3/04/2025

Titles & IDs
Public title
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
Scientific title
A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy
Secondary ID [1] 0 0
2024-514974-39-00
Secondary ID [2] 0 0
LP352-303
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

Experimental: LP352 - Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 1 - Visit 3), followed by maintenance period (Visit 4 - Visit 14) and then taper/down titration period (Visit 15 - Visit 17).


Treatment: Drugs: LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants reporting Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) and AEs leading to discontinuation
Timepoint [1] 0 0
Up to 61 Weeks
Primary outcome [2] 0 0
Number of Participants With Clinically Significant Changes in Chemistry parameters
Timepoint [2] 0 0
Up to 61 Weeks
Primary outcome [3] 0 0
Number of Participants With Clinically Significant Changes in Hematology parameters
Timepoint [3] 0 0
Up to 61 Weeks
Primary outcome [4] 0 0
Number of Participants With Clinically Significant Changes in Urinalysis
Timepoint [4] 0 0
Up to 61 Weeks
Primary outcome [5] 0 0
Number of participants with clinically significant changes in vital signs
Timepoint [5] 0 0
Up to 61 Weeks
Primary outcome [6] 0 0
Number of participants with clinically significant changes in physical examinations
Timepoint [6] 0 0
Up to 61 Weeks
Primary outcome [7] 0 0
Number of participants with clinically significant changes in growth parameters
Timepoint [7] 0 0
Up to 61 Weeks
Primary outcome [8] 0 0
Number of participants with clinically significant changes in electrocardiogram (ECG) parameters
Timepoint [8] 0 0
Up to 61 Weeks
Primary outcome [9] 0 0
Number of participants with postive responses to Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [9] 0 0
Up to 61 Weeks
Primary outcome [10] 0 0
Number of participants with positive responses to Patient Health Questionnaire-9 (PHQ-9) and Question 9
Timepoint [10] 0 0
Up to 61 Weeks
Secondary outcome [1] 0 0
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
Timepoint [1] 0 0
Baseline and up to 55 weeks
Secondary outcome [2] 0 0
Percentage of participants with = 50% Reduction in countable motor seizures during Treatment compared to Baseline [Visit 1 of LP352-301 and LP352-302]
Timepoint [2] 0 0
Baseline and up to 55 weeks
Secondary outcome [3] 0 0
Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline [Visit 1 of LP352-301 and LP352-302]
Timepoint [3] 0 0
Baseline and up to 55 weeks

Eligibility
Key inclusion criteria
* The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
* Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
* Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
* The participant or legal representative must be willing and able to provide written informed consent
* 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.
Minimum age
2 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The participant is receiving exclusionary medications.
* Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing =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
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
12/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
324
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
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06908226