Arbaclofen in Children and Adolescents With ASD (NCT03682978) | Clinical Trial Compass
CompletedPhase 2
Arbaclofen in Children and Adolescents With ASD
France, Spain, United Kingdom124 participantsStarted 2019-09-19
Plain-language summary
AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.
Who can participate
Age range5 Years – 17 Years
SexALL
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Inclusion criteria
✓. Signed Written Informed Consent
✓. Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care. Participants who do not have the capacity to consent will give developmentally appropriate assent.
✓. Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
✓. The subject's parent/caregiver/LAR must be able to speak and understand the local language where the study is conducted sufficiently to understand the nature of the study and to allow for the completion of all study assessments. The same parent/caregiver/LAR must be capable of providing reliable information about the subject's condition, agree to oversee the administration of study drug, and accompany the subject to all clinic visits.
✓. Patient must be able to speak and understand the local language where the study is conducted sufficiently to understand the nature of the study and to allow for the completion of all study assessments.
✓. Type of Participant and Target Disease Characteristics
✓. Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria
What they're measuring
1
Effect of Arbaclofen vs. placebo on social function
✓. Complex language as defined in ADOS-2 to qualify for a Module 3 or 4.
Exclusion criteria
✕. Medical Conditions
✕. Prior/Concomitant Therapy
✕. Subjects who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin). Only occasional benzodiazepine (or derivative drugs) use (PM, i.e. at night) will be allowed.
✕. Subjects 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.
✕. Subjects who have taken another investigational drug within the last 30 days.