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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.

Överblick

Status
Registrering genom inbjudan
Fas
FAS2
Sponsor
MapLight Therapeutics
Inskrivningsmål
120
Starta
01 jun 2023
Beräknad slutförande
01 dec 2027
Autismspektrumstörning

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.
  • Du kan sluta delta när som helst utan att det påverkar din vanliga vård.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. I have already finished the ML-004-002 study in the last 3 months.
  2. I am between 12 and 46 years old.
  3. I have a diagnosis of Autism Spectrum Disorder.
  4. I have a trusted person who can help report on my symptoms.
  5. I can swallow tablets whole.
  6. I haven't had any uncontrolled seizures in the last 6 months.
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

Participating in research always comes with potential benefits and risks. A potential benefit of taking part is contributing to a better understanding of ML-004 beyond previous studies, which could help others with autism in the future. However, there's no guarantee that you will personally benefit from taking the medication. Potential risks could include experiencing side effects from the medication. You will be closely monitored for any such effects. It's vital to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Platser (21)

  • Harmonex Neuroscience Research
    Verifierat postnummer
    Dothan, USA
  • Sydvästra Forsknings- och Resurscentret för Autism
    Verifierat postnummer
    Phoenix, USA
  • Cortica Healthcare
    Verifierat postnummer
    Glendale, USA
  • NRC Research Institute
    Verifierat postnummer
    Orange, USA
  • Cortica
    Verifierat postnummer
    San Rafael, United States
  • Yale Child Study Center
    Verifierat postnummer
    New Haven, USA
  • The Children's Research Institute
    Verifierat postnummer
    Washington D.C., USA
  • Abba Medical Group
    Verifierat postnummer
    Miami, USA
  • APG Research, LLC
    Verifierat postnummer
    Orlando, USA
  • University of South Florida Psychiatry and Behavioral Neurosciences
    Verifierat postnummer
    Tampa, USA
  • Neurobehavioral Medicine Group
    Verifierat postnummer
    Bloomfield Hills, United States
  • University of Missouri, Thompson Center for Autism & Neurodevelopment
    Verifierat postnummer
    Columbia, United States

Vanliga frågor

Vad är huvudsyftet med denna studie?

The main purpose is to learn more about the safety of ML-004 when taken over a longer time by people with autism.

Vem kan delta i denna studie?

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.

Vad händer om jag ändrar mig om att delta?

You are free to leave the study at any point, and it won't affect your regular medical care.

Hur du får reda på mer

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