NCT05163717.

Study name	INP105 proof‐of‐concept study for the acute treatment of agitation in adolescents with ASD (CALM 201)
Methods	Cross‐over trial of single‐dose INP105 (olanzapine) versus placebo
Participants	Inclusion criteria: male and female aged 12‐17 years confirmed ASD diagnosis admitted as an inpatient to a behavioral unit prior to informed consent displays episodes of moderate to severe agitation Exclusion criteria: hypersensitivity to olanzapine currently diagnosed with a genetic or other syndromic form of neurodevelopmental disorder seizure in the past 6 months history of severe head trauma, stroke, endocrine disorder, or cardiovascular disease history of hypotension currently on a chronic dose of olanzapine, or currently taking ciprofloxacin, enoxacin, fluvoxamine, or carbamazepine Location/setting: USA Target sample size: 32 participants Gender: details not provided Mean age: details not provided IQ: details not provided Concomitant medications: details not provided Previous medications: details not provided
Interventions	Intervention (olanzapine): a single dose of 5 mg of olanzapine Comparator (placebo): a single dose of equivalent placebo
Outcomes	Primary outcomes: irritability (measured using the ABC‐I subscale (Aman 1985) aggression (measured using the Overt Aggression Scale) AEs Secondary outcomes: none reported Timing of outcome assessments: AEs measured up to 48 h post‐dose; aggression and irritability measured 30 minutes post‐dose.
Starting date
Contact information	Contact name: Stephen Shrewsbury Contact details: sshrewsbury@impelpharma.com
Notes	Study start date: June 2022 Study end date: estimated to be January 2023 Source of funding: Impel NeuroPharma Inc. Conflicts of interest: details not provided