A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
This important study, called the DEEp OCEAN Study, is investigating a new medicine, LP352, for children and adults who have a severe and complex form of epilepsy known as Developmental and Epileptic Encephalopathies (DEE). These conditions involve difficult-to-control seizures and affect a person's development. The study aims to find out if LP352 can effectively reduce seizures and whether it is safe and well-tolerated. Participants will receive either LP352 or a placebo (a dummy medicine) in a randomised way, meaning it's decided by chance. Doctors and patients won't know who is receiving which, to make the results as fair as possible. The study involves several stages, including screening, taking the medication, and follow-up, and is expected to last about two years in total.
At a glance
What is this study about?
This research study is about finding a new way to help children and adults who live with a condition called Developmental and Epileptic Encephalopathies, often shortened to DEE. DEE isn't just one condition; it's a group of severe epilepsy types that can cause frequent, hard-to-control seizures and can also impact a person's learning and development significantly.
The study is testing a new medicine called LP352. The main goal is to see if LP352 can help reduce the number of seizures people with DEE experience and to understand if it's a safe treatment for them. Because we need to be sure the new medicine really works, some people in the study will get LP352, and others will get what's called a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This helps researchers compare the results fairly and understand if any changes are truly due to LP352.
By taking part in this study, you could be helping doctors learn more about DEE and potentially discover a new treatment option that could improve the lives of many people with this challenging condition. This kind of research is vital for advancing our understanding and care for complex epilepsies.
Key takeaways
- This study is testing a new medicine (LP352) for severe epilepsy called DEE.
- It aims to see if LP352 reduces seizures and is safe for children and adults (ages 2-65).
- Participants will receive either LP352 or a placebo (dummy medicine).
- The study lasts about two years and involves regular clinic visits and seizure diaries.
- Specific eligibility rules apply, including your type of DEE and current seizure frequency.
- You can withdraw from the study at any point without affecting your ongoing care.
Who may be eligible?
To join this study, children and adults generally need to be between 2 and 65 years old. The study is particularly looking for people diagnosed with certain types of DEE, including Lennox-Gastaut Syndrome (LGS) or other specific forms of DEE. For those with LGS, seizures usually started before age 8, they have a history of certain types of seizures (like tonic or tonic-atonic), and their development has been affected. An EEG test, which looks at brain activity, would also show particular patterns.
For those with other types of DEE, seizures generally started before age 5, their development has been affected, they have had many different seizure types, and an EEG would show specific patterns. Anyone joining must currently experience at least 4 specific types of motor seizures each month, and these seizures should have been consistently occurring over the past three months.
You also need to be taking 1 to 4 anti-seizure medicines at a steady dose for at least 4 weeks before the study starts. You cannot have Dravet Syndrome or a particular gene mutation that causes it, as this study is not for those conditions. Importantly, you or your caregiver must be willing and able to keep a diary of your seizures and other study information.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you or the person with DEE between 2 and 65 years old?
- Is the DEE diagnosis either Lennox-Gastaut Syndrome (LGS) or a similar severe epilepsy with early onset and developmental impact?
- Do you or the person with DEE currently have at least 4 specific types of motor seizures per month, consistently over the last 3 months?
- Are you / they taking 1 to 4 anti-seizure medications at a steady dose for at least 4 weeks?
- Are you or your caregiver able and willing to keep a seizure diary throughout the study?
- Have you been told you do NOT have Dravet Syndrome or a related genetic mutation?
What does participation involve?
If you decide to take part, the study will last about two years (24 months). It starts with a 'Screening' phase to check if you're suitable. After that, there's a 'Titration period' where the dose of the study medicine (LP352 or placebo) is slowly increased to find the right amount. This is followed by a longer 'Maintenance period' where you take the steady dose. Towards the end, there's a 'Taper period' where the medicine is slowly reduced, and finally, a 'Follow-Up' to check on you after the treatment ends.
Throughout the study, you'll have regular visits to the clinic, where doctors and nurses will check on your health, monitor your seizures, and make sure you're doing okay. You or your caregiver will need to keep a diary of your seizures and any changes you notice. You'll be given either the new medicine LP352 or a dummy medicine called a placebo. All tests, medicines, and medical care specifically related to the study will be provided at no cost, and you can withdraw from the study at any time.
Potential risks and benefits
Locations (110)
- Arkansas Children's Hospital - PINVerified postcodeLittle Rock, United States· Recruiting
- Children's Hospital Los Angeles - PINVerified postcodeLos Angeles, United States· Recruiting
- David Geffen School of Medicine at UCLAVerified postcodeLos Angeles, United States· Recruiting
- The Stanford Division of Child NeurologyVerified postcodePalo Alto, United States· Recruiting
- UCSF Children's HospitalVerified postcodeSan Francisco, United States· Recruiting
- Children's Hospital Colorado.Verified postcodeAurora, United States· Recruiting
- Children's National Medical CenterVerified postcodeWashington D.C., United States· Recruiting
- NW FL Clinical Research Group, LLCVerified postcodeGulf Breeze, United States· Recruiting
- University of Miami - 1120 NW 14th StVerified postcodeMiami, United States· Recruiting
- Nicklaus Children's Hospital - PINVerified postcodeMiami, United States· Recruiting
- Research Institute of Orlando LLCVerified postcodeOrlando, United States· Completed
- University of South Florida - 2 Tampa General CircleVerified postcodeTampa, United States· Recruiting
Common questions
What is DEE?
DEE stands for Developmental and Epileptic Encephalopathies. It's a group of severe epilepsy conditions that cause frequent seizures and can also affect a person's development and learning.
What is LP352?
LP352 is a new investigational medication being tested in this study to see if it can help reduce seizures in people with DEE.
What does 'placebo' mean?
A placebo is adummy medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare if the new medicine truly works.
How long will the study last?
The study is expected to last about two years (24 months) in total, including different phases like screening, taking the medicine, and follow-up.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Email contact via H. Lundbeck A/S
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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