Dravet SyndromeNCT06149663
Intermediate-Size Expanded Access Protocol (EAP) for LP352
A study testing LP352 in people with Dravet Syndrome and Lennox Gastaut Syndrome, run by Longboard Pharmaceuticals at 22 sites in 2 countries.
Trial summary
This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathies
- What is being tested?
- LP352
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 22 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (<18 years of age) as required by local regulations.
- Participant with DEE who has successfully completed an LP352 Clinical Trial.
- Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
- Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.
Who cannot join
- Participant was discontinued from an LP352 Clinical Trial for any reason.
- Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States19 sites
- Available
Colorados Childrens Hospital
Aurora, Colorado, 80045
- Available
Children's Neuro Consultants of Austin
Austin, Texas, 78757
- Available
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
- Available
Northwestern Medicine Feinberg School of Medicine
Chicago, Illinois, 60611
- Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Available
Rancho Research Institute
Downey, California, 90242
- Available
Corewell Health
Grand Rapids, Michigan, 49506
- Available
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, 32502
- Available
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
- Available
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
- Available
New York University (NYU)
New York, New York, 10012
- Available
Lenox Hill Hospital
New York, New York, 10075
- Available
Research Institute of Orlando
Orlando, Florida, 32792
- Available
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Available
Providence Brain & Spine
Portland, Oregon, 97225
- Available
University of Utah
Salt Lake City, Utah, 84132
- Available
University of California Benioff Childrens Hospital
San Francisco, California, 94609
- Available
Washington University School of Medicine
St Louis, Missouri, 63110
- Available
University of Southern Florida
Tampa, Florida, 33620
Australia3 sites
- Available
Austin Hospital, Heidelberg
Heidelberg, Melbourne, 3084
- Available
Alfred Hospital
Melbourne, Melbourne, 3004
- Available
Children's Health Queensland Hospital and Health Service,
South Brisbane, Queensland, 4101
About this study
Official title: Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)
This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.
- Being tested
- LP352
- Keywords
- CDKL5 deficiency disorder, developmental and epileptic encephalopathy, Dravet Syndrome, epilepsy, Lennox Gastaut Syndrome, treatment resistant epilepsy, tuberous sclerosis complex
- Medical subject headings
- Epilepsies, Myoclonic, Lennox Gastaut Syndrome, CDKL5 deficiency disorder, Epilepsy, Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP352Drug
LP352 will be administered as a liquid either orally or through a G-tube or Percutaneous Endoscopic Gastrotomy (PEG) tube.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Longboard Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149663
- Sponsor's protocol ID
- LP352-EAP-01
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)
- ClinicalTrials.gov ID
- NCT06149663
- Acronym / sponsor ID
- LP352-EAP-01
- Keywords
- CDKL5 deficiency disorder, developmental and epileptic encephalopathy, Dravet Syndrome, epilepsy, Lennox Gastaut Syndrome, treatment resistant epilepsy, tuberous sclerosis complex
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Longboard PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.
Study design
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (<18 years of age) as required by local regulations.
- Participant with DEE who has successfully completed an LP352 Clinical Trial.
- Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
- Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.
Key exclusion criteria (2 listed)
- Participant was discontinued from an LP352 Clinical Trial for any reason.
- Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP352LP352 will be administered as a liquid either orally or through a G-tube or Percutaneous Endoscopic Gastrotomy (PEG) tube. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LP352 in people with Dravet Syndrome and Lennox Gastaut Syndrome, run by Longboard Pharmaceuticals at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Longboard Study Contact (858-999-8858, clinicalstudies@longboardpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.