drugset / Trial / NCT05163808
A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a 2-part study, with each part having a unique set of objectives for male adolescents aged 9 to \< 18 years with fragile X syndrome (FXS). Part 1 is an open-label, single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and 50 mg, while Part 2 is double-blind (DB) and randomized between two treatment groups (Study Drug and Placebo).
Timeline
- Start
- 2022-03-29
- Primary completion
- 2025-09-02
- Completion
- 2025-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | zatolmilast | Small molecule | 15 mg | — |
| Comparator | zatolmilast | Small molecule | 25 mg | — |
| Comparator | zatolmilast | Small molecule | 50 mg | — |