Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
This research study is looking into a new medicine called carisbamate for people who have Lennox-Gastaut Syndrome (LGS). LGS is a severe form of epilepsy that causes different types of seizures. The main goal of the study is to find out if carisbamate can help reduce the number of 'drop seizures' (seizures that cause someone to fall) compared to a dummy medicine (placebo). The study includes children and adults aged 4 to 55 years. Researchers will also be checking how safe carisbamate is and if people can tolerate it well. This is a Phase 3 study, meaning it's one of the final stages of testing before a medicine might be approved for wider use.
At a glance
What is this study about?
This research study is carefully examining a new drug called carisbamate, also known as YKP509, as an additional treatment for people living with Lennox-Gastaut Syndrome (LGS). LGS is a complex and often challenging type of epilepsy that typically begins in childhood and can cause various kinds of seizures, including those that lead to falls, often called 'drop seizures'. The study specifically wants to see if adding carisbamate to a person's existing seizure medicines can significantly lower the number of these drop seizures. They will compare carisbamate to a placebo, which looks like the study drug but has no active medicine, to clearly see its effects.
Beyond just counting drop seizures, the study also has other important aims. It will look at whether carisbamate can reduce the total number of all types of seizures that a person experiences. A big part of any new medicine study is also to check its safety. So, researchers will carefully monitor how the body reacts to carisbamate, looking for any side effects and how well people tolerate the medicine. They will also study how the body processes carisbamate once it's taken.
Clinical trials like this are crucial for developing new and potentially more effective treatments. By involving both children and adults between the ages of 4 and 55, the study hopes to gather comprehensive information to understand if carisbamate could be a valuable new option for managing LGS, which can be a very difficult condition to treat effectively.
Key takeaways
- Tests a new medicine, carisbamate, for Lennox-Gastaut Syndrome (LGS).
- Aims to reduce 'drop seizures' in people aged 4-55.
- Compares carisbamate to a placebo (dummy medicine).
- Also checks for safety, side effects, and overall seizure reduction.
- Participants continue taking their current seizure medications.
Who may be eligible?
To be considered for this study, you or your child must have a confirmed diagnosis of Lennox-Gastaut Syndrome (LGS). This means you should have a history of more than one type of seizure, including at least one that causes you to drop, and earlier tests (like an EEG brain scan) should have shown changes typical for LGS. There should also be a history of developmental delays, which are common with LGS. Participants must be aged between 4 and 55 years old when they join, and their LGS must have started before they turned 11.
Additionally, you must have experienced at least two 'drop seizures' (seizures that cause a fall or potential fall) during the four weeks just before the study begins. These drop seizures need to be clearly countable. You also need to be taking between one and four other seizure medications, and their doses should have been stable for at least a month before starting the study. Any special diets or brain stimulators used for epilepsy must also be stable for the same period.
It's important that parents or caregivers of participants are able to keep accurate records of seizures. There are also specific rules about medicines and treatments containing cannabidiol, and for women who could get pregnant, they must either not be able to have children (e.g., post-menopausal, surgically sterile) or be using effective birth control.
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.
- Do I/my child have a confirmed diagnosis of Lennox-Gastaut Syndrome?
- Is the participant aged between 4 and 55 years?
- Did LGS begin before the participant was 11 years old?
- Has the participant had at least two 'drop seizures' in the last 4 weeks?
- Is the participant currently taking 1 to 4 stable seizure medications?
- Can a parent or caregiver accurately keep a seizure diary?
What does participation involve?
If you join this study, you would be given either the new medicine, carisbamate, or a dummy medicine (placebo). Neither you nor your doctor would know which one you are taking until after the study is over. You would continue to take your current seizure medications alongside the study medicine. Throughout the study, you'll have regular appointments where doctors will check your health, ask about any side effects, and do tests. Parents or caregivers will need to keep a careful diary of any seizures that occur. The total duration of the study and how many visits are needed will be explained by the study team.
Potential risks and benefits
Locations (71)
- Stanford University HospitalVerified postcodePalo Alto, United States· Recruiting
- University of Florida Health Science CenterVerified postcodeJacksonville, United States· Completed
- AdventHealthVerified postcodeOrlando, United States· Completed
- Pediatric Epilepsy and Neurology SpecialistsVerified postcodeTampa, United States· Recruiting
- University of South FloridaVerified postcodeTampa, United States· Completed
- Axcess Medical ResearchVerified postcodeWellington, United States· Completed
- Consultants in Epilepsy and Neurology PLLCVerified postcodeBoise, United States· Completed
- Bluegrass Epilepsy Research, LLCVerified postcodeLexington, United States· Completed
- University Medical Center New OrleansVerified postcodeNew Orleans, United States· Completed
- Johns Hopkins HospitalVerified postcodeBaltimore, United States· Recruiting
- Mid-Atlantic Epilepsy and Sleep CenterVerified postcodeBethesda, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Completed
Common questions
What is Lennox-Gastaut Syndrome (LGS)?
LGS is a severe form of epilepsy that causes many different types of seizures, often starting in childhood, and can be challenging to treat.
What are 'drop seizures'?
These are seizures that cause a person to suddenly fall or slump, due to a sudden loss of muscle control or a stiffening of the body.
What is a 'placebo'?
A placebo is a dummy medicine that looks just like the real study drug but contains no active ingredients. It helps researchers compare the effects of the new medicine.
How long will the study last?
The full duration of your participation in the study will be explained in detail by the study team before you decide to join.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Barbara Remes
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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