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

NCT04823052 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-08

No results posted yet for this study

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

  • Fragile X Syndrome

Interventions

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

Sponsors & Collaborators

  • Healx Limited

    lead INDUSTRY

Principal Investigators

  • Elizabeth Berry-Kravis · Rush University Medical Center & Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-10-19
Completion
2022-10-19
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823052 on ClinicalTrials.gov