Phase 3 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You (or your legal representative) must be willing and able to sign a consent form approved by an ethics board
• You must have a diagnosis of Autism Spectrum Disorder (ASD) based on standard diagnostic guidelines (DSM-5)
• You must have already taken part in a related study called AIMS-2 CT1, where you were between 5 and 17 years old when you joined
• Any medication you take that affects behaviour must have been at the same dose for at least 6 weeks before the screening visit, and must stay the same throughout the study
• Any therapy or behavioural support you receive must have been the same for at least 3 months before screening, and must stay the same during the study
• If you have a history of seizures, you must currently be on stable seizure medication and have had no seizures for at least 6 months, OR have been seizure-free for 3 years if you are not on seizure medication
• You must be between 7 and 23 years old (inclusive) at the time of giving consent
• You must live with, or have regular contact (at least twice a week) with, the parent or carer who will be interviewed for the study
• If you are a girl or woman who has started her periods, you must have a negative pregnancy test before joining
• If you are a girl or woman who could become pregnant and is sexually active, you must agree to use a highly effective form of contraception during the study (confirm with trial site for the full list of accepted methods)
• If you are a male participant with a female partner who could become pregnant, you must agree to certain conditions around contraception (confirm with trial site for full details)

Who may not be able to join:

• You have any other health condition that could affect how the study runs, make the results hard to interpret, or put your health at risk
• You are currently taking certain medications related to a brain chemical called GABA — including racemic baclofen, vigabatrin, tiagabine, riluzole, gabapentin, or pregabalin (other than arbaclofen as part of the AIMS-2 CT1 study)
• Your behaviour-affecting medication dose has not been stable for at least 6 weeks before your screening visit
• You have recently started or changed any behavioural, educational, or dietary programme, or plan to do so during the study (normal school holidays do not count as a change)
• You have taken part in another clinical trial using an experimental treatment within the last 30 days
• You have a significant medical condition affecting your blood, hormones, heart, breathing, kidneys, liver, or digestive system — mild and stable childhood conditions (such as mild asthma or constipation) may be acceptable (confirm with trial site)
• You are unable to swallow or take medications by mouth
• You have had an allergic reaction to a medication called racemic baclofen in the past
• You have a rare inherited condition involving problems processing galactose or lactose (such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption)
• You currently have an active stomach ulcer
• You have a condition called porphyria
• You are currently misusing alcohol or illegal drugs, based on standard diagnostic guidelines (DSM-5)
• You have previously taken part in a clinical trial using arbaclofen, other than the AIMS-2 CT1 study
• You are currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.