A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC OLE)
This research study, called TrustTSC OLE, is investigating a new medication, ganaxolone, for adults who experience seizures due to Tuberous Sclerosis Complex (TSC). This is an important step to understand if ganaxolone can be safely used to help manage seizures in people living with TSC. The study will closely monitor participants' health, including any side effects, to make sure the treatment is safe. It will also track how often seizures occur to see if the medicine helps. By participating, you could help doctors learn more about improving treatment options for TSC-related epilepsy.
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¿De qué trata este estudio?
This study is looking at a new medicine called ganaxolone for people who have epilepsy because of a condition called Tuberous Sclerosis Complex (TSC). TSC can cause many different health problems, and epilepsy (seizures) is a common one. Finding effective and safe ways to control these seizures is very important for improving people's daily lives.
The main goal of this study is to check how safe ganaxolone is. This means doctors will be carefully looking for any side effects the medicine might cause and how serious they are. They will also see if people need to stop taking the medicine or reduce their dose because of these side effects. Your overall health will be checked regularly throughout the study.
The study will also measure how well ganaxolone works at reducing seizures. Doctors will compare how many seizures participants have before starting the medicine with how many they have during the study. This helps them understand if the medicine is actually helping to control the epilepsy. They will also look at how the medicine affects a person's general well-being and quality of life.
Puntos clave
- This study is for adults with Tuberous Sclerosis Complex (TSC) who experience epilepsy.
- It tests a new medicine called ganaxolone.
- The main goals are to check the medicine's safety and see if it helps reduce seizures.
- Participation involves regular health checks and recording seizure information.
- You could gain access to a new treatment and help advance medical knowledge.
¿Quién puede ser elegible?
This study is particularly for adults who have epilepsy due to Tuberous Sclerosis Complex (TSC).
If you are 18 years old or older and have a diagnosis of TSC that causes epilepsy, you might be able to take part.
Both men and women are welcome to participate. The study team will need to check your medical history to make sure this study is right for you.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes 18 años o más?
- Do you have Tuberous Sclerosis Complex (TSC)?
- Does your TSC cause you to have epilepsy (seizures)?
- Are you able to attend regular appointments for check-ups?
¿En qué consiste la participación?
If you join this study, you will be given the medicine ganaxolone. You'll have regular visits with the study team where they will check your health. These checks will include things like measuring your blood pressure and heart rate, taking blood samples for lab tests, and having an electrocardiogram (ECG) to check your heart. Doctors will also check your physical condition and how you are developing.
You will need to keep a record of your seizures. The study will look at how your seizure frequency changes over time, especially during the first year of treatment. There will also be questionnaires to assess your quality of life. The study will last for a long period, with particular focus on the first year of treatment for some measurements.
Riesgos y beneficios potenciales
Ubicaciones (5)
- —No verificadoAlemania
- —No verificadoEspaña
- —No verificadoItalia
- —No verificadoFrancia
- —No verificadoBélgica
Preguntas comunes
What is ganaxolone?
Ganaxolone is the new medicine being studied to help people with epilepsy caused by Tuberous Sclerosis Complex (TSC).
What is Tuberous Sclerosis Complex (TSC) related epilepsy?
It's when someone has seizures (epilepsy) that are caused by the genetic condition Tuberous Sclerosis Complex.
¿Cuánto tiempo durará el estudio?
The study is a long-term one, and some key measurements, like seizure frequency and quality of life, will be closely looked at during the first year.
Will I know if the medicine is working for me?
The study team will monitor your seizure frequency and overall health, and you'll have regular check-ups to discuss your progress.
What if I have side effects?
The study team will closely watch you for any side effects, and they will be there to help you manage them. Your safety is their top priority.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.