NCT06413537

Study of SPG601 in Adult Men With Fragile X Syndrome

A Phase 2a, Randomized, Double-Blinded, Study Evaluating the Neurophysiologic vs Clinical Effects of Single-Dose SPG601 and Placebo in Adult Men With Fragile X Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Spinogenix · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.

Detailed description

This study is a Phase 2 randomized, double blind, placebo-controlled, cross over, single dose of SPG601 and matching Placebo in patients with Fragile X syndrome. This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo. Participants will receive a dose of either SPG601 or placebo at first visit, and will cross over to receive the other product at the second visit.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	SPG601	synthetic small molecule
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-07-05
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-05-14
• Last updated: 2025-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study