NCT06334419

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Craig Erickson · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Gaboxadol	Drug: Gaboxadol 10 mg as a single dose (two 5mg capsules)
DRUG	Placebo	Two placebo capsules

Timeline

• Start date: 2024-01-29
• Primary completion: 2025-05-13
• Completion: 2025-06-24
• First posted: 2024-03-28
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study