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New treatment option for Autism Spectrum Disorders
Official title 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
ClinicalTrials.gov ID: NCT07655115
What this study is testing
What is Arbaclofen?
Arbaclofen is an investigational medicine, being studied as a potential treatment for autism spectrum disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 64
You may be able to join if
- Signed Written Informed Consent a.Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent...
- 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...
- Current psychotherapeutic/psychosocial interventions affecting behaviour stable for 3 months prior to screening and expected to be stable during the...
You likely can't join if
- Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their...
- Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g...
- Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose...
- Participating in programs including non-pharmacologic educational, behavioural, and/or dietary interventions affecting behaviour, participation in...
- 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)...
See the full eligibility 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...
- 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...
- 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)
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Barcelona, Spain
- Madrid, Spain
- Salamanca, Spain
- Zamora, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Barcelona, Spain; Madrid, Spain; Salamanca, Spain; Zamora, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.