drugset / Trial / NCT04823052

Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40

NCT04823052 ↗

Phase 2 Withdrawn Healx Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to investigate the safety, tolerability and efficacy of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in males with Fragile X Syndrome (FXS) with confirmed full FMR1 mutation treated over a 10 week period in an outpatient setting.

Timeline

Start
2022-05-25
Primary completion
2022-10-19
Completion
2022-10-19

Outcome

Outcome not reported

Stopped (Enrollment): “Healx has experienced delays to the site activation of the study and this has had an adverse impact on the recruitment timeline which is delaying the progress of other projects in our FXS programme.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gaboxadol Unknown — —
Comparator Sulindac Small molecule — —

Indications