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Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS)

NCT06334419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-23

No results posted yet for this study

Summary

This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be given single dose gaboxadol (10 mg) or matched placebo at each of these visits to take orally. Thus, all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

Gaboxadol

Drug: Gaboxadol 10 mg as a single dose (two 5mg capsules)

DRUG

Placebo

Two placebo capsules

Sponsors & Collaborators

  • Healx Limited

    collaborator INDUSTRY

  • Craig Erickson

    lead OTHER

Principal Investigators

  • Cragi A Erickson, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2025-05-13
Completion
2025-06-24
FDA Drug
Yes

Countries

  • United States

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 NCT06334419 on ClinicalTrials.gov