Can a single dose predict autism treatment success?
NCT ID NCT07655115
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autism spectrum disorders are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
5 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGParis, 75019, France
-
Complejo Asistencial De Zamora Hospital Provincial De Zamora
RECRUITINGZamora, 49020, Spain
-
Hospital Clinic De Barcelona
RECRUITINGBarcelona, 08036, Spain
-
Hospital General Universitario Gregorio Marañón
RECRUITINGMadrid, 28007, Spain
-
Hospital Universitario De Salamanca
RECRUITINGSalamanca, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sensory-Friendly swim program aims to keep kids with autism safer in the water
- Can teens with autism drive safely? new study investigates
- Can video coaching help parents connect with autistic toddlers?
- New study aims to transform autism care by measuring what really matters
- Talking therapy shows promise for autism Self-Harm
- Eye-Tracking reveals clues to autism in Children's gaze