drugset / Trial / NCT04823052
Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gaboxadol | Unknown | — | — |
| Comparator | Sulindac | Small molecule | — | — |