Trials / Withdrawn
WithdrawnNCT04823052
Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40
A Phase 2, Placebo-controlled, Adaptive Design Study to Explore the Safety and Efficacy of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) and Possible Other Treatments in Adolescent and Adult Males With Fragile X Syndrome (FXS)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Healx Limited · Industry
- Sex
- Male
- Age
- 13 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sulindac (HLX-0201), dose strength 1 | Sulindac (HLX-0201) Capsule |
| DRUG | Sulindac (HLX-0201), dose strength 2 | Sulindac (HLX-0201) Capsule |
| DRUG | Placebo | Placebo Capsule |
| DRUG | Gaboxadol (HLX-0206) | Gaboxadol (HLX-0206) Capsule |
Timeline
- Start date
- 2022-05-25
- Primary completion
- 2022-10-19
- Completion
- 2022-10-19
- First posted
- 2021-03-30
- Last updated
- 2022-12-08
Locations
10 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04823052. Inclusion in this directory is not an endorsement.