drugset / Trial / NCT04987762
Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.
Timeline
- Start
- 2021-08-03
- Primary completion
- 2022-04-27
- Completion
- 2022-04-27
Outcome
Outcome not reported
Stopped: “due to administrative reasons not related to efficacy or safety.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 12.5 mg | Oral |
| Subject | Methylphenidate | Small molecule | 25 mg | Oral |
| Subject | Methylphenidate | Small molecule | 35 mg | Oral |
| Subject | Methylphenidate | Small molecule | 45 mg | Oral |
| Subject | Methylphenidate | Small molecule | 55 mg | Oral |
| Subject | Methylphenidate | Small molecule | 70 mg | Oral |