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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Autism Spectrum Disorder in children and adolescents. The treatment being tested is called Arbaclofen, which is an oral solution. The study aims to understand how a single dose of Arbaclofen can predict long-term responses in improving social functions in individuals with autism. The trial will include different doses of Arbaclofen such as 5mg, 10mg, 15mg, and 20mg, and will also involve a placebo group for comparison.

The purpose of the study is to explore the potential of Arbaclofen in enhancing social interactions and communication in young people with autism. Participants will receive the treatment over a period of time, and their responses will be monitored to assess any changes in their social behavior. The study will also look at specific biological markers, which are measurable indicators in the body, to see how they relate to the treatment's effectiveness.

Throughout the study, participants will have regular visits to monitor their progress and any side effects. The trial will last for a maximum of 13 weeks, during which the participants' social functions will be evaluated. This research hopes to provide valuable insights into how Arbaclofen can be used to support individuals with autism in their social development.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of autism spectrum disorder and ensuring that current treatments affecting behavior have been stable for the required period.

    Participants must be between 7 to 23 years of age and meet specific residential and reproductive criteria. A negative pregnancy test is required for females of childbearing potential.

  2. Step 2

    Treatment phase

    The treatment phase involves the administration of arbaclofen in the form of an oral solution. The available dosages are 5mg, 10mg, 15mg, and 20mg. The specific dosage and frequency will be determined by the study protocol.

    This phase aims to predict long-term response to arbaclofen based on a single dose response during a placebo-controlled, randomized, single-dose, double-blind stage.

  3. Step 3

    Monitoring and evaluation

    Participants will undergo regular monitoring and evaluation to assess the treatment's impact. This includes measuring the latency of N170 change at week 14, which is a primary endpoint of the study.

    Secondary endpoints include comparing the latency of N170 change between different treatment arms.

  4. Step 4

    Follow-up

    The study includes a follow-up period to observe any long-term effects of the treatment. This phase is crucial for understanding the sustained impact of arbaclofen on social function in children and adolescents with autism spectrum disorders.

    The estimated end date for the trial is July 31, 2025.

Who can join the trial?

14 criteria

  • The participant or their legal representative must sign a written consent form, showing they understand and agree to the study. If the participant is a child, they will give their agreement in a way suitable for their age. When they turn 18, they will sign a new consent form.
  • The participant must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests.
  • The participant's parent or caregiver must speak and understand the local language well enough to understand the study and complete all assessments. They must also provide reliable information about the participant's condition, agree to oversee the study drug administration, and accompany the participant to all clinic visits.
  • The participant must speak and understand the local language well enough to understand the study and complete all assessments.
  • The participant must have a diagnosis of **autism spectrum disorder** according to the DSM-5 criteria, which is a guide used by doctors to diagnose mental health conditions.
  • The participant must have been part of a previous study called AIMS-2 CT1, and they will be between 7 to 23 years old at the time of consent.
  • The participant's current medication affecting behavior must have been stable for at least 6 weeks before the study starts and should remain stable during the study.
  • The participant's current therapy or social interventions affecting behavior must have been stable for 3 months before the study starts and should remain stable during the study.
  • If the participant has a history of seizures, they must be on stable medication and seizure-free for 6 months before the study, or seizure-free for 3 years if not on medication.
  • The participant must be between 7 to 23 years old at the time of providing consent.
  • The participant must live with or have regular contact (at least twice a week) with the parent or caregiver who is interviewed for the study.
  • Female participants who can become pregnant must have a negative pregnancy test.
  • Females who can become pregnant and are sexually active must agree to use a highly effective form of birth control.
  • Male participants with female partners who can become pregnant must agree to certain conditions regarding birth control.
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Investigated drugs

Arbaclofen is a medication being studied for its potential to improve social function in children and adolescents with Autism Spectrum Disorders. The trial aims to understand how a single dose of this medication might predict long-term benefits for patients.

What is already known about the treatment

Arbaclofen – Arbaclofen is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating autism spectrum disorder, particularly focusing on improving social function in children and adolescents. The medication works by modulating the activity of GABA-B receptors in the brain, which are involved in neurotransmission and can influence social behavior. Arbaclofen is classified as a GABA-B receptor agonist, and its use in autism is still under investigation to determine its long-term efficacy and safety.

Investigated diseases

Autism Spectrum Disorder – Autism Spectrum Disorder (ASD) is a developmental condition that affects communication, behavior, and social interaction. Individuals with ASD may have difficulty understanding social cues, forming relationships, and expressing themselves verbally or non-verbally. The disorder is characterized by a wide range of symptoms and abilities, which can vary significantly from person to person. Some individuals may exhibit repetitive behaviors or have specific interests, while others may have sensory sensitivities. ASD typically appears in early childhood and can impact daily functioning and learning. The progression of symptoms can change over time, with some individuals experiencing improvements in certain areas as they grow older.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508407-20-00Protocol codeAIMS-2-CT2Estimated enrolment105 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

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