A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopat… (NCT06908226) | Clinical Trial Compass
By InvitationPhase 3
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
United States, Australia, France324 participantsStarted 2025-02-12
Plain-language summary
This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.
Who can participate
Age range
2 Years – 66 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
* Participant has a body weight of ≥10 kg.
* G-tubes/PEG tubes (if applicable) should be in stable and good working condition. Nasogastric tubes are not allowed except for short-term management.
* Has at least one reliable and consistent parent, legal guardian, or caregiver during 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 LAR must provide informed consent and the participant will need to assent (as per local regulations) before participation in the study. If the participant cannot provide consent or assent (ie, due to developmental status), the investigator should document why it was not obtained.
* The participant and/or authorized representative is willing to provide written consent or assent to allow the investigator and the investigator's staff to consult with the participant's medical caregivers and the medical monitor during Screening and during participation in the study.
* All participants of childbearing potential must have a negative urine or serum pregnancy (human chorionic gonadotropin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants reporting Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) and AEs leading to discontinuation
Timeframe: Up to 61 Weeks
2
Number of Participants With Clinically Significant Changes in Chemistry parameters
Timeframe: Up to 61 Weeks
3
Number of Participants With Clinically Significant Changes in Hematology parameters
Timeframe: Up to 61 Weeks
4
Number of Participants With Clinically Significant Changes in Urinalysis
Timeframe: Up to 61 Weeks
5
Number of participants with clinically significant changes in vital signs
Timeframe: Up to 61 Weeks
6
Number of participants with clinically significant changes in physical examinations
Timeframe: Up to 61 Weeks
7
Number of participants with clinically significant changes in growth parameters