Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40
Public ClinicalTrials.gov record NCT04823052. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04823052
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- Sulindac (HLX-0201), dose strength 1 Drug
- Sulindac (HLX-0201), dose strength 2 Drug
- Placebo Drug
- Gaboxadol (HLX-0206) Drug
Drug
Eligibility (public fields only)
- Age range
- 13 Years to 40 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2022
- Primary completion
- Oct 18, 2022
- Completion
- Oct 18, 2022
- Last update posted
- Dec 7, 2022
2022
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center & Children's Hospital | Chicago | Illinois | 60612 | — |
| Kennedy Krieger Insitute | Baltimore | Maryland | 21205 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 10655 | — |
| Icahn School of Medicine (Mount Sinai) | New York | New York | 10029 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04823052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2022 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04823052 live on ClinicalTrials.gov.