Autism Spectrum DisordersPhase 3NCT07655115
Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th
A Phase 3 study testing Arbaclofen in people with Autism Spectrum Disorders, run by Hospital General Universitario Gregorio Marañon at 5 sites in 2 countries.
Trial summary
study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and… Read more about this study
- Who is it for?
- Ages 0 to 64 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Arbaclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Nov 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Spain4 sites, 4 recruiting
- Recruiting
Hospital Clinic De Barcelona
Barcelona, 08036
Rosa Calvo, PhD, +34932279974, rcalvo@clinic.cat
Rosa Calvo, PhD
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Maria José Parellada, PhD, +34 91 4265005, parelladahggm@gmail.com
María José Parellada, PhD
- Recruiting
Hospital Universitario De Salamanca
Salamanca
Ricardo Canal-Bedia, PhD, +34638766776, rcanal@usal.es
Ricardo Canal-Bedia, PhD
- Recruiting
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Zamora, 49020
Manuel Angel Franco, PhD, +34669462622, mfrancom@saludcastillayleon.es
Manuel Angel Franco, PhD
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux De Paris
Paris, 75019
Richard Delorme, PhD, +31140034130, richard.delorme@aphp.fr
Richard Delorme, PhD
About this study
Official title: A Follow-Up Shiftability Study of Arbaclofen With an Open-Label Extension for the Study of Biomarkers in Children and Adolescents With Autism Spectrum Disorders.
study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders
- Conditions
- Autism Spectrum Disorders
- Being tested
- Arbaclofen, Placebo
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbaclofenDrug
initial single dose arbaclofen
PlaceboOther
initial single dose placebo
| Study group | Role | What they receive |
|---|---|---|
| arbaclofen | Experimental | Not described Receives: Drug: Arbaclofen |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in power in the low frequency bands (theta/alpha) (between visits 1 and 2).
To predict long term response to arbaclofen based on a single dose response during the placebo-controlled randomized single dose double blind stage.
Measured: baseline to day 7
Secondary outcomes (3)
Latency of N170 change (between visits 1 and 2).
To test the effect of arbaclofen on an EEG biomarker for response to faces during the placebo-controlled randomized single dose double blind stage.
Measured: baseline to day 7
Change of Autism Impact Measure (AIM total (Kanne et al., 2014b, Silkey et al., 2023) and subscales. • Change in the Social Responsiveness Scale (SRS total and subscales; Constantino & Gruber, 2012a).
To explore the effect of arbaclofen on other measures of defining features of autism.
Measured: from baseline to end of treatment
Change in power in the higher frequency bands (gamma/beta); connectivity in the theta and alpha bands; (between visits 1 and 2).
To explore EEG marker sensitive to excitatory/inhibitory changes.
Measured: baseline to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start20 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An initial single dose double-blind, placebo-controlled cross-over (SDDBPCCO) shiftability study, will be followed on autistic population by a 10-week open-label study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655115
- Sponsor's protocol ID
- AIMS-2-CT2
- Other IDs
- 2023-508407-20-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be entered in a GDPR compliant EDC by individual sites, and after thorough checks shared with the sponsor, according to the CTA. Data will possibly be shared after thorough data cleaning and checks of de-identification of individuals, with other parties of the consortium, if participants have agreed to that in the Informed Consent Form. Examples of these data would be EEG data, that would be uploaded in a secured server, and analysed by a consortium partner.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-Up Shiftability Study of Arbaclofen With an Open-Label Extension for the Study of Biomarkers in Children and Adolescents With Autism Spectrum Disorders.
- ClinicalTrials.gov ID
- NCT07655115
- Acronym / sponsor ID
- AIMS-2-CT2
- Conditions
- Autism Spectrum Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An initial single dose double-blind, placebo-controlled cross-over (SDDBPCCO) shiftability study, will be followed on autistic population by a 10-week open-label study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment).
| Arm | Type | Receives |
|---|---|---|
| arbaclofen | Experimental | Drug: Arbaclofen |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 0 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arbaclofeninitial single dose arbaclofen | Drug | arbaclofen |
| Placeboinitial single dose placebo | Other | placebo |
Primary outcome
Change in power in the low frequency bands (theta/alpha) (between visits 1 and 2).
Time frame: baseline to day 7
To predict long term response to arbaclofen based on a single dose response during the placebo-controlled randomized single dose double blind stage.
3 secondary outcomes
Latency of N170 change (between visits 1 and 2).
Time frame: baseline to day 7
Change of Autism Impact Measure (AIM total (Kanne et al., 2014b, Silkey et al., 2023) and subscales. • Change in the Social Responsiveness Scale (SRS total and subscales; Constantino & Gruber, 2012a).
Time frame: from baseline to end of treatment
Change in power in the higher frequency bands (gamma/beta); connectivity in the theta and alpha bands; (between visits 1 and 2).
Time frame: baseline to day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be entered in a GDPR compliant EDC by individual sites, and after thorough checks shared with the sponsor, according to the CTA. Data will possibly be shared after thorough data cleaning and checks of de-identification of individuals, with other parties of the consortium, if participants have agreed to that in the Informed Consent Form. Examples of these data would be EEG data, that would be uploaded in a secured server, and analysed by a consortium partner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arbaclofen in people with Autism Spectrum Disorders, run by Hospital General Universitario Gregorio Marañon at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in power in the low frequency bands (theta/alpha) (between visits 1 and 2). (time frame: baseline to day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.