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Arbaclofen

Clinical trials are investigating Arbaclofen in children and adolescents with autism spectrum disorder. These studies look at whether Arbaclofen can help with social function and whether biomarker changes may predict treatment response. They also assess study design details such as safety, response, and measured outcomes.

Table of Contents

Clinical trial overview

The available trial is a Phase 3 interventional study of Arbaclofen in children and adolescents with autism spectrum disorder.[1] Its full title describes it as a follow-up shiftability study with an open-label extension for biomarker research related to social function.[1]

The study is designed to learn whether a single-dose response can help predict long-term response to Arbaclofen.[1] It also focuses on biomarkers, which are measurable body signals used to help understand treatment effects.[1]

Study design and treatment groups

The trial includes a placebo-controlled, randomized, double-blind single-dose stage.[1] In simple terms, placebo-controlled means some participants receive an inactive treatment for comparison, randomized means assignment is by chance, and double blind means neither participants nor researchers know the treatment during that part of the study.[1]

The study also includes an open-label extension, which is a follow-up part of the trial where the treatment is known.[1] The intervention list shows oral Arbaclofen in 5 mg, 10 mg, 15 mg, and 20 mg strengths.[1]

Who the trial is for

This study targets children and adolescents with autism spectrum disorder.[1] The source data does not provide more detailed inclusion or exclusion rules, so the exact participation criteria are not listed here.[1]

What the study measures

The main outcome is the change in power in the low frequency brain wave bands, called theta and alpha, between visit 1 and visit 2.[1] This type of measurement helps researchers see whether brain activity changes during the study.[1]

The brief summary says the study aims to predict long-term response to Arbaclofen based on the response seen during the placebo-controlled randomized single-dose double-blind stage.[1] The trial title also shows that the research is focused on biomarkers for treatment of social function.[1]

Trial status and enrollment

The trial status is listed as Authorised.[1] The planned enrollment is 105 participants.[1]

Because the study is a single listed trial in the source data, the current evidence here is limited to this one research program.[1]

Key terms explained

Autism spectrum disorder is a condition that affects social communication and behavior, and it is the population studied in this trial.[1] Social function means how a person interacts and communicates with other people in daily life.[1]

Biomarkers are measurable body signals that may help researchers understand treatment response.[1] In this study, the biomarker outcome uses theta/alpha brain wave bands, which are low frequency activity patterns measured between visits.[1]

Trial ID Phase Condition studied Status Enrollment
2023-508407-20-00 Phase 3 Autism spectrum disorder Authorised 105

FAQ

  • What is being studied in Arbaclofen clinical trials? The trial is studying Arbaclofen in children and adolescents with autism spectrum disorder. It focuses on social function and on biomarkers, which are measurable body signals used in research.
  • Who can take part in these trials? The study is for children and adolescents with autism spectrum disorder. The trial data does not give more detailed participation rules.
  • What phase is the Arbaclofen trial? The trial is a Phase 3 study. Phase 3 trials usually test a treatment in a larger group to better understand its effects.
  • What outcome is the trial measuring? The main outcome is change in power in low frequency brain wave bands, called theta and alpha. This is measured between visit 1 and visit 2.
  • Is the trial open to follow-up treatment? Yes. The study includes an open-label extension, which means participants may receive Arbaclofen in a follow-up part of the study where the treatment is known.

Ongoing Clinical Trials on Arbaclofen

  • Study on Arbaclofen for Improving Social Function in Children and Adolescents with Autism Spectrum Disorder

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Autism spectrum disorder: A condition that affects social communication and behavior. The trial studies children and adolescents with this diagnosis.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group of people.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Open-label extension: A follow-up part of a study where participants know what treatment they are receiving.
  • Placebo-controlled: A study design where one group receives an inactive treatment called a placebo for comparison.
  • Randomized: Participants are assigned to study groups by chance.
  • Double blind: A study design where neither the participants nor the researchers know who gets which treatment during a part of the study.
  • Biomarker: A measurable sign in the body that may help researchers understand disease or treatment response.
  • Social function: How a person communicates and interacts with other people in daily life.
  • Theta/alpha bands: Low frequency brain wave ranges measured in research studies.

References

  1. https://clinicaltrials.gov/study/2023-508407-20-00