drugset / Trial / NCT07439510

A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants

NCT07439510 ↗

Phase 2/3 Not yet recruiting 248 enrolled Spinogenix
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 2b/3, randomized, double-blind, placebo-controlled, 2-part study will evaluate the efficacy, safety and tolerability of different dose regimens of SPG601 in adult male participants with Fragile X syndrome.

Timeline

Start
2026-03-01
Primary completion
2030-02-01
Completion
2030-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator SPG601 Small molecule — —

Indications