Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1. Intranasal oxytocin · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1. Intranasal Oxytocin | EXPERIMENTAL | Intranasal oxytocin spray (30 IU twice daily) for 12 months in the double-blinded phase followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase |
| 2. Placebo | PLACEBO_COMPARATOR | Intranasal placebo spray (30 IU twice daily (total 60 IU per day) for 12 months followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase |
| Name | Type | Description |
|---|---|---|
| 1. Intranasal oxytocin spray | DRUG | 30 IU, twice daily for 12 months in the experimental arm in double-blinded phase |
| 2. Intranasal placebo spray | DRUG | 30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase |
| 3. Intranasal Oxytocin spray | DRUG | 30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase |
Inclusion Criteria: 1. Ages 6 to 18 years old at Randomization 2. BMI greater than or equal to the 5th percentile 3. Expert clinical diagnosis of ASD 4. Availability of parent/guardian to provide informed consent Exclusion Criteria: 1. Fragile X, tuberous sclerosis, William's syndrome, Angelman's...