LONG-TERM INTERVENTIONAL FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIAL AND COMPARISON WITH AN UNTREATED COHORT OF CHILDREN WITH PRADER-WILLI SYNDROME (OTBB3 FOLLOW-UP)
This study is a follow-up for children with Prader-Willi Syndrome who previously participated in a trial called OTBB3. Researchers are checking in with these children for up to four years to see how they are growing and developing. They want to understand if the nasal spray treatment, called Otwillo, they received earlier has had a lasting impact on their health and well-being. This information will also be compared to a group of children with Prader-Willi Syndrome who didn't receive this specific treatment. The main goals are to track any new health issues, medicines, surgeries, or therapies the children might need, providing valuable insights into the long-term effects of the treatment and the condition itself.
En un coup d'œil
De quoi parle cette étude ?
This study is a long-term check-up for children who previously took part in an important trial called OTBB3. All these children have a condition called Prader-Willi Syndrome. The main reason for this follow-up is to understand how these children are doing as they grow older, specifically up to four years after they were first involved in the treatment study. Researchers are particularly interested in seeing if the nasal spray medication, called Otwillo, which some of them received during the earlier trial, has had any lasting effects on their health and development. They will also compare their progress with other children with Prader-Willi Syndrome who didn't receive this specific treatment.
The team wants to learn more about the overall health of these children. This means keeping an eye out for any new health problems, illnesses, or unexpected effects that might come up over time. They will also collect information about any medications the children are taking, any operations they might have had, or any special therapies, like physiotherapy, that they are receiving. By gathering all this information, the researchers hope to get a clearer picture of how Prader-Willi Syndrome affects children in the long run and how early treatments might influence their journey.
Ultimately, the goal is to help scientists and doctors better understand Prader-Willi Syndrome and to improve future treatments and care for children living with this condition. This study is considered a "Phase II exploratory" type, which means it helps researchers get early insights and decide if a treatment has enough promise to be studied in larger groups of people later on. Your involvement, or your child's involvement, helps lead to better understanding and support for others with Prader-Willi Syndrome.
Points clés
- This study is a long-term follow-up for children who were in the OTBB3 trial for Prader-Willi Syndrome.
- It aims to understand the long-term health and development of these children.
- No new medication is given; it's purely to observe and collect health information.
- The study will track health changes, medicines, surgeries, and therapies over up to four years.
- Your child's participation helps improve future care and understanding of Prader-Willi Syndrome.
Qui peut être éligible ?
This study is specifically for children who previously participated in the OTBB3 clinical trial. If your child was part of that initial study, they may be asked to join this long-term follow-up.
There are no specific age limits for joining this follow-up, other than having been a part of the original study; it includes children of all ages who were in the OTBB3 trial. Both boys and girls who meet this requirement are welcome to be considered for participation.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Was my child previously part of the OTBB3 clinical trial?
- Does my child have Prader-Willi Syndrome?
- Am I willing to provide ongoing health information about my child for up to four years?
En quoi consiste la participation ?
If you decide to take part, your child will be followed for up to four years. This mostly involves regular check-ups where the study team will gather information about your child's health. They will ask about any new health issues, doctor visits, medications your child is taking, any surgeries they've had, or any therapies like physical therapy. This can be done through visits to the clinic or by talking to you over the phone. You won't receive any new medication in this follow-up study, it's purely to observe how the children are doing after their earlier treatment. The total duration of your child's involvement could be up to four years.
Risques et avantages potentiels
Emplacements (1)
- —Non vérifiéFrance
Questions fréquentes
What is Prader-Willi Syndrome?
Prader-Willi Syndrome is a rare genetic condition that affects many parts of the body, leading to issues like constant hunger, learning difficulties, and weak muscles.
What was the previous OTBB3 study?
The OTBB3 study was an earlier clinical trial that tested a nasal spray medicine called Otwillo in children with Prader-Willi Syndrome.
Will my child get new medicine in this study?
No, this is a follow-up study. Your child will not receive any new medicine. It's about observing their health after the previous trial.
Combien de temps l'étude durera-t-elle pour mon enfant ?
Your child's involvement in this follow-up study could last for up to four years.
Pourquoi cette étude est-elle importante ?
It's important because it helps doctors and scientists understand the long-term effects of treatments and how Prader-Willi Syndrome affects children over time, leading to better care for others.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
Discussion communautaire
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