ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
This research is an open-label extension study for a new treatment called ML-004, designed for people aged 12 to 46 with autism spectrum disorder. 'Open-label' means both you and your doctor will know you are taking the study medication. It's for people who have already taken part in a previous ML-004 study (ML-004-002). The main goal is to understand more about the safety of ML-004 when taken over a longer period. Around 120 young people and adults are expected to take part across different centres. This study is testing ML-004 in both immediate-release (IR) and extended-release (ER) tablet forms.
एक नजर में
यह अध्ययन किस बारे में है?
This study is called ML-004 and it's looking into a new medication for people with autism spectrum disorder (ASD). It's designed for individuals aged between 12 and 46 years old. This particular trial is a follow-up, called an 'open-label extension study'. This means it's for people who have already completed an earlier study involving ML-004, and everyone involved – the participants and the doctors – will know that the study medication is being given. The main reason for this study is to gather more information about how safe ML-004 is when it's used for a longer time.
Autism spectrum disorder affects how people communicate and interact with others, and how they experience the world around them. While there are approaches to support individuals with autism, this study is exploring a new potential medication. It's important to understand that this study is not primarily looking at how well the drug works, but rather its safety profile.
By carefully monitoring people taking ML-004 over time, researchers hope to build a more complete picture of any potential side effects or safety concerns. This information is a crucial step in the process of developing new treatments and ensuring they are as safe as possible for patients.
मुख्य निष्कर्ष
- This study is a follow-up for people who have already taken ML-004 in a previous trial.
- The main focus is to check the safety of ML-004 for young people and adults with autism.
- Participants will know they are taking the study medication.
- It's for individuals aged 12 to 46 who meet specific health requirements.
- Regular health checks will be part of taking part.
- You can stop participating at any time without affecting your normal care.
कौन पात्र हो सकता है?
To be considered for this study, you must have already finished the previous ML-004-002 study within the last 90 days. You need to be between 12 and 46 years old when the study starts, and have a clear diagnosis of autism spectrum disorder. It's important that you have someone who can reliably report on your symptoms, such as a family member or carer.
You also need to be able to swallow the study tablets. Your body mass index (BMI) should be 18 or above. If you are taking any other medications for your mental health or any other treatments, they need to have been stable for at least four weeks before you join the study.
There are some reasons why you might not be able to join. These include having certain conditions like Rett syndrome or childhood disintegrative disorder, or if you've had seizures that aren't well controlled, especially in the last six months. The study also cannot include individuals who are at a significant risk of suicidal behaviour, have uncontrolled high blood pressure, or if you are pregnant or breastfeeding. These checks are in place to make sure the study is as safe as possible for everyone involved.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- I have already finished the ML-004-002 study in the last 3 months.
- I am between 12 and 46 years old.
- I have a diagnosis of Autism Spectrum Disorder.
- I have a trusted person who can help report on my symptoms.
- I can swallow tablets whole.
- I haven't had any uncontrolled seizures in the last 6 months.
भागीदारी में क्या शामिल है?
If you decide to take part in this study, you will be given the study medication, ML-004, in tablet form. Both you and the study team will know you are receiving the medication. You'll have regular visits to the study clinic where the research team will check on your health and any effects of the medication. This will involve physical examinations, blood tests, and discussions about how you're feeling and any symptoms you might have. Your care partner will also play a role in reporting on your symptoms. The exact number of visits, tests, and the total duration of your participation will be explained in detail by the study team, but it's an extension of a previous study, so it will involve ongoing assessments.
संभावित जोखिम और लाभ
स्थान (21)
- Harmonex Neuroscience Researchसत्यापित पोस्टकोडडोथन, संयुक्त राज्य अमेरिका
- Southwest Autism Research and Resource Centerसत्यापित पोस्टकोडफीनिक्स, संयुक्त राज्य अमेरिका
- Cortica Healthcareसत्यापित पोस्टकोडग्लेनडेल, संयुक्त राज्य अमेरिका
- NRC Research Instituteसत्यापित पोस्टकोडऑरेंज, संयुक्त राज्य अमेरिका
- Corticaसत्यापित पोस्टकोडSan Rafael, United States
- Yale Child Study Centerसत्यापित पोस्टकोडन्यू हेवन, संयुक्त राज्य अमेरिका
- The Children's Research Instituteसत्यापित पोस्टकोडवॉशिंगटन डी.सी., संयुक्त राज्य अमेरिका
- Abba Medical Groupसत्यापित पोस्टकोडमियामी, संयुक्त राज्य अमेरिका
- APG Research, LLCसत्यापित पोस्टकोडऑरलैंडो, संयुक्त राज्य अमेरिका
- University of South Florida Psychiatry and Behavioral Neurosciencesसत्यापित पोस्टकोडटाम्पा, संयुक्त राज्य अमेरिका
- Neurobehavioral Medicine Groupसत्यापित पोस्टकोडBloomfield Hills, United States
- University of Missouri, Thompson Center for Autism & Neurodevelopmentसत्यापित पोस्टकोडColumbia, United States
सामान्य प्रश्न
इस अध्ययन का मुख्य उद्देश्य क्या है?
The main purpose is to learn more about the safety of ML-004 when taken over a longer time by people with autism.
इस अध्ययन में कौन भाग ले सकता है?
It's for people aged 12 to 46 with autism who have already completed a previous ML-004 study.
Will I know if I'm taking the study medication?
Yes, this is an 'open-label' study, meaning everyone will know you are receiving the study medication, ML-004.
What kind of medication is ML-004?
ML-004 is a tablet that might be given in an immediate-release or extended-release form.
अगर मैं भाग लेने के बारे में अपना मन बदल लूँ तो क्या होगा?
You are free to leave the study at any point, and it won't affect your regular medical care.
और अधिक जानने के लिए कैसे पता करें
किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.
भाग लेने में रुचि रखते हैं?
चर्चा
समुदाय चर्चा
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