Parellada 2021.

Study name	Arbaclofen in children and adolescents with ASD (AIMS2‐CT1)
Methods	16‐week parallel trial of arbaclofen versus placebo
Participants	Inclusion criteria: outpatients male and female aged 5‐17 years with a diagnosis of ASD if on psychotropic medications, must remain stable throughout the study written informed consent to participate in the trial Exclusion criteria: pregnant women any serious medical conditions, including unstable epilepsy history of drug abuse hypersensitivity or allergy to arbaclofen enroled in a different intervention study inability to take oral medication Setting/location: France, Spain and the UK Sample size: target sample size is 130
Interventions	Intervention (arbaclofen) for 16 weeks: maximum of 15 mg 3 times daily for children aged 5‐11 years, and a maximum of 20 mg/day for children aged 12‐17 years Comparator (placebo for 16 weeks): equivalent placebo
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) adverse effects Secondary outcomes: health‐related QoL (unclear the measure used) Timing of outcome assessments: unclear
Starting date	September 2019
Contact information	Contact person: Inge Winter Contact details: I.Winter@umcutrecht.nl
Notes	Source of funding: "This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under the grant agreement No. 777394 for the project AIMS‐2‐TRIALS. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program, EFPIA, Autism Speaks, Autistica, and the Simons Foundation". Conflicts of interest: various authors had a consultancy or other working relationship with pharmaceutical companies Trial registry ‐ NCT03682978