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Can a single dose predict autism treatment success?

NCT ID NCT07655115

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug arbaclofen can improve social function, anxiety, and quality of life in children and adolescents with autism. Participants first receive a single dose of arbaclofen or placebo to see if brain-wave changes can predict who will benefit. Then everyone gets arbaclofen for 10 weeks to measure real-world effects. The trial involves 103 participants aged 5–17 who have already taken part in a related study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
arbaclofen
What this could lead to
If it works, this could point toward a treatment that eases social anxiety and improves quality of life for some children with autism.
What could go wrong
This is still an early-stage test of how well a single dose predicts longer-term response. The main trial is small (103 participants) and may not show clear benefits for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed Written Informed Consent a.Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent form * Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria * Participation in the AIMS-2 CT1 (ages at recruitment 5 to 17). * Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study * Current psychotherapeutic/psychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the duration of the study * Participants with a history of seizure disorder must currently be receiving stable treatment with anticonvulsant medication and must have been seizure free for 6 months prior to screening or must be seizure free for 3 years prior to screening if not currently on a stable (\>3 months) dose of antiepileptics * Male or female participants 7 to 23 years of age at the time of providing consent, inclusive. * Reside or regular contact (at least twice a week) with the parent/carer who is interviewed for the study. * Negative pregnancy test for females of childbearing potential (participant has experienced onset of menses) * Females of childbearing potential who are sexually active must agree to use a highly effective form of contraception (i.e., existing surgical sterilization, complete or abstinence or a combination of two affective forms of contraception, such as, for example, condoms plus hormonal treatment). Please, refer to Appendix 4 for a complete list of acceptable contraception methods.(protocol) * Male participants with female partners of childbearing potential are eligible to participate if they agree to the conditions stated in section 8.2.1.(protocol) Exclusion Criteria: * Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin) other than arbaclofen in the context of AIMS-2 CT1 * Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose during the 6 weeks prior to the screening visit and for the duration of the study. * Participating in programs including non-pharmacologic educational, behavioural, and/or dietary interventions affecting behaviour, participation in these programs must have been continuous during the 3 months prior to screening and participants or their parent/caregiver/LAR may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming * Participants who have taken another investigational drug within the last 30 days. * Participants with evidence of any significant haematological, endocrine, cardiovascular (including uncorrected symptomatic congenital heart disease), respiratory, renal, hepatic, or gastrointestinal disease, not including mild common paediatric diseases in these areas that are stable (e.g. mild asthma, constipation, etc.), as judged by the investigator. * Participants who are not able to take oral medications. * Participants who have a history of hypersensitivity to racemic baclofen * Participants with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine. * Active peptic ulceration as Baclofen stimulates gastric acid secretion. * Porphyria. * Participants who are currently engaged in illicit drug use or alcohol abuse, according to DSM-5 criteria. * Participants who have previously participated in a clinical trial with arbaclofen (other than our AIMS-2-CT1). * Women who are breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique Hopitaux De Paris

    RECRUITING

    Paris, 75019, France

  • Complejo Asistencial De Zamora Hospital Provincial De Zamora

    RECRUITING

    Zamora, 49020, Spain

  • Hospital Clinic De Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario De Salamanca

    RECRUITING

    Salamanca, Spain

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