Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Withdrawn Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04823052

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.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 3:34 PM EDT

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)

Study identification

NCT ID
NCT04823052
Recruitment status
Withdrawn
Study type
Interventional
Phase
Phase 2
Lead sponsor
Healx Limited
Industry
Enrollment
Not listed

Conditions and interventions

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 Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04823052 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →