Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02184767 | Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication | PHASE1 | COMPLETED | 30 | — | — | Jul 1, 2014 | May 1, 2015 | Nov 12, 2021 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| ADASUVE® | EXPERIMENTAL | oral inhalation using a single-use, hand-held, inhaler; dosage determined by the investigator according the participants weight |
| Name | Type | Description |
|---|---|---|
| ADASUVE® | DRUG | ADASUVE® 2.5, 5, or 10 mg |
Inclusion 1. Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient. 2. The patient is a boy or girl 10 through 17 years of age. 3. The patient is within the 2.5 to 97.5 percentile for body mass index (BMI) on the basis of ...