A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
This study, called DEEp OLE, is for children and adults with a severe form of epilepsy known as Developmental and Epileptic Encephalopathy (DEE). This includes conditions like Dravet Syndrome and Lennox-Gastaut Syndrome. The main goal is to see how safe LP352 is when taken for a longer time, how well it helps control seizures, and how the body processes the medication. Participants will be those who have already completed an earlier study (LP352-301 or LP352-302). The study involves different stages of medication, from starting a dose to a stable period, and then gradually stopping the drug, lasting about 14 months in total. It aims to gather more information to help people with these challenging conditions.
At a glance
What is this study about?
This research study is about a new medication called LP352. It’s for children and adults who have a serious type of epilepsy called Developmental and Epileptic Encephalopathy (DEE). This includes specific conditions like Dravet Syndrome and Lennox-Gastaut Syndrome, which cause frequent and often difficult-to-control seizures.
The main purpose of this study is to learn more about LP352. Researchers want to understand how safe it is when people take it for a longer time, how well it helps to reduce seizures, and how the body handles the drug. This particular study is for people who have already been taking LP352 in two earlier studies (LP352-301 or LP352-302).
By gathering more information on the long-term effects of LP352, doctors can better understand if it's a good treatment option for people living with these challenging forms of epilepsy. This can help improve future care and quality of life for patients.
Key takeaways
- This study is for people already taking LP352 for DEE.
- It aims to check the long-term safety and effectiveness of LP352.
- The study lasts about 14 months and involves different phases of medication.
- Participants must be aged 2 to 66 years and weigh at least 10 kg.
- Close monitoring for side effects will be provided.
- You can leave the study at any time.
Who may be eligible?
To join this study, you must have already taken part in and successfully finished one of two earlier studies (LP352-301 or LP352-302). Your doctor will also need to believe that continuing to take LP352 would be helpful for you.
You must have been diagnosed with a type of DEE, such as Dravet Syndrome or Lennox-Gastaut Syndrome. Participants need to weigh at least 10 kilograms (about 22 pounds) and be between 2 and 66 years old. If you use a feeding tube (G-tube or PEG tube), it needs to be in good working order.
It's important to have a reliable parent, guardian, or carer throughout the study. You, or your legal representative, must be willing to give written permission to take part. If you are a woman who could become pregnant, you must have had a negative pregnancy test recently and agree to use effective contraception during the study. You also need to agree not to share personal medical details about the study on social media or online until the study is over.
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.
- Have I already finished LP352 Study 301 or 302?
- Do I have a diagnosis of DEE (like Dravet or Lennox-Gastaut Syndrome)?
- Am I between 2 and 66 years old?
- Do I weigh at least 10 kg?
- Do I have a reliable person (parent, guardian, or caregiver) who can help me throughout the study?
- If I am a woman who could get pregnant, am I willing to use effective contraception?
What does participation involve?
If you decide to take part, the study will last about 14 months. It starts with a 'Screening' phase to make sure you're suitable. Then, there will be a 'Titration' period where the dose of LP352 might be slowly adjusted. After that, you'll enter the 'Maintenance' period where you'll be on a stable dose of the medication. Towards the end, there will be a 'Taper' period where the medication will be gradually reduced, followed by a 'Follow-Up' visit to check on you after you've stopped the drug. Throughout the study, you'll have regular visits to the clinic for assessments, which will include checking your general health, seizure activity, and how you're reacting to LP352. Your doctors and the study team will be in close contact with your usual medical caregivers.
Potential risks and benefits
Locations (68)
- Arkansas Children's Hospital - PINVerified postcodeLittle Rock, United States
- David Geffen School of Medicine at UCLAVerified postcodeLos Angeles, United States
- The Stanford Division of Child NeurologyVerified postcodePalo Alto, United States
- UCSF Children's HospitalVerified postcodeSan Francisco, United States
- Childrens Hospital Colorado - PINVerified postcodeAurora, United States
- NW FL Clinical Research Group, LLCVerified postcodeGulf Breeze, United States
- University of Miami - 1120 NW 14th StVerified postcodeMiami, United States
- Research Institute of Orlando LLCVerified postcodeOrlando, United States
- University of South Florida - 2 Tampa General CircleVerified postcodeTampa, United States
- Pediatric Epilepsy and Neurology SpecialistsVerified postcodeTampa, United States
- Consultants In Epilepsy and Neurology PLLCVerified postcodeBoise, United States
- Mid-Atlantic Epilepsy and Sleep CenterVerified postcodeBethesda, United States
Common questions
What is DEE?
DEE stands for Developmental and Epileptic Encephalopathy. It's a group of severe epilepsies that start early in life and can cause frequent seizures and developmental problems.
What is LP352?
LP352 is a new medication being tested to treat seizures in people with certain types of epilepsy, including DEE.
How long will the study last?
The study will last for approximately 14 months, including different periods for starting, taking, and stopping the medication, followed by a final check-up.
Can I join if I haven't been in a previous LP352 study?
No, this study is only for those who have already completed specific previous studies (LP352-301 or LP352-302) with the same drug.
Will I have to pay to be in the study?
No, you will not have to pay for the study medication or the extra visits and tests related to the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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