drugset / Trial / NCT05163808

A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome

NCT05163808

Phase 2/3 Completed 163 enrolled Tetra Discovery Partners
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

EvaluationDrugModalityDoseRoute
Comparator zatolmilast Small molecule 15 mg
Comparator zatolmilast Small molecule 25 mg
Comparator zatolmilast Small molecule 50 mg

Indications