Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients with Lennox-Gastaut Syndrome
This study is investigating a new medicine called Clemizole HCl for people living in the UK with Lennox-Gastaut Syndrome, a serious form of epilepsy where seizures are difficult to control. Researchers want to find out if adding Clemizole HCl to a person's existing epilepsy medication can help reduce how often and how severe their seizures are. The study is a "Phase III" trial, which means it's one of the final steps to see if the medicine is safe and effective before it could be considered for wider use. Some participants will receive the new medicine, and others will receive a placebo (dummy pill) to compare the effects fairly.
Em resumo
Sobre o que é este estudo?
This clinical trial is designed to see if a new medicine, called Clemizole HCl, can help people who have a severe type of epilepsy known as Lennox-Gastaut Syndrome (LGS). LGS often causes many different kinds of seizures that are hard to get under control with standard treatments. The goal of this study is to find out if adding Clemizole HCl to a person's current epilepsy medication can help reduce the number and severity of these seizures.
The study is set up so that some people will receive the new medicine, while others will receive a 'placebo', which looks like the medicine but contains no active ingredients. This is a common and important way to fairly test if a new medicine works better than no treatment at all, or if any changes are just due to other factors. Neither the patients nor their doctors will know who is getting the real medicine and who is getting the placebo, which makes the results more reliable.
Throughout the study, doctors and researchers will carefully track participants' seizures and their overall well-being. They will measure how much the number of seizures changes, how many seizure-free days a person has, and how their daily life is affected. This will help them understand if Clemizole HCl makes a real difference for people with Lennox-Gastaut Syndrome.
Pontos principais
- This study tests a new medicine for severe epilepsy (Lennox-Gastaut Syndrome).
- It aims to see if the medicine reduces seizure frequency.
- Participants will receive either the new medicine or a dummy pill (placebo).
- You will be closely monitored for health changes and side effects.
- The study involves regular clinic visits and seizure tracking.
Quem pode ser elegível?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
There might be other specific reasons why someone wouldn't be able to join, such as other medical conditions you have or other medicines you're taking. This is to make sure the study is safe for everyone involved and that the results are clear.
If you're interested, your doctor can check all the detailed requirements with you to see if this study would be a good fit.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Do you have Lennox-Gastaut Syndrome?
- Você consegue comparecer a consultas regulares na clínica?
- Are you currently on stable epilepsy medication?
- Are you willing to keep a seizure diary?
O que envolve a participação?
If you decide to take part in this study, you will be given either the new medicine (Clemizole HCl) or a placebo (a dummy pill) to take alongside your usual epilepsy medication. You won't know which one you are receiving. Initially, there will be a 'titration phase', where the dose of the study medicine is slowly increased to find the right level for you. This will be followed by a 'maintenance phase' where you continue taking that dose.
Throughout the study, you will have regular visits to the clinic so doctors can monitor your health, how often and how severe your seizures are, and any side effects you might experience. These visits will involve assessments, possibly some questionnaires about your well-being, and keeping a diary of your seizures. The total duration of your involvement, including all phases and follow-up, will be explained in detail by the study team.
Riscos e benefícios potenciais
Localizações (6)
- —Não verificadoItália
- —Não verificadoEspanha
- —Não verificadoHungria
- —Não verificadoRomênia
- —Não verificadoChéquia
- —Não verificadoPolônia
Perguntas frequentes
What is Lennox-Gastaut Syndrome?
Lennox-Gastaut Syndrome is a severe and rare form of epilepsy that begins in childhood and causes frequent and varied types of seizures, often difficult to control with medicine.
What does 'multicenter' mean?
'Multicenter' means the study is being run in several hospitals or clinics at different locations, which helps gather more information and include a wider range of patients.
O que é um 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to fairly compare if the new medicine works better than no treatment.
Saberei se estou recebendo o medicamento real ou o placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you're receiving the active medicine or the placebo. This helps ensure the results are unbiased.
What is a 'Phase III' trial?
A Phase III trial is a large study that comes after earlier, smaller studies. It's designed to confirm if a new medicine is safe and effective over a longer period and in more people.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
Discussão da comunidade
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