As I said, there’s a fair bit of overlap in the exploratory efficacy outcomes being used in the four Phase 2 trials. But there’s also a fair bit of overlap in the measurement scales being used with those that might be used used in autism.
All trials are using Clinical Global Impression-Severity (CGI-I) and CGI-Improvement (CGI-S) scales, adapted to make them disease specific. The CGI-I and CGI-S scales are also used in the diagnosis of autism.
All trials are using the Vineland Adaptive Behaviour Scales -3 (VABS). VABS measures adaptive behaviour and supports the diagnosis of development delays, intellectual and developmental disabilities and autism.
All trials are using the Quality of Life Inventory-Disability (QI-Disability) scale. This measures quality of life across the spectrum of intellectual disability, including in autism.
All trials are using the Impact of Childhood Neurological Disability (INCD), which assesses the impact of paediatric epilepsy and concomitant behavioural, cognitive, and physical/neurologic disability. Epilepsy is 10 times more common in the autistic than in the general population.
Three of the trials are using the Aberrant Behaviour Checklist (ABC-2), which assesses irritability, social withdrawal, stereotypic behaviour, hyperactivity/noncompliance and inappropriate speech. The ABC also has application in autism.
Three of the trials are using the Children's Sleep Habit Questionnaire (CSHQ), which is also a widely used measure in autism.
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