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Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

NCT05418049 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-23

No results posted yet for this study

Summary

The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

Baclofen

30mg - Supplied as 10mg and 20mg tablets

DRUG

Memantine

two 10 mg tablets

DRUG

Roflumilast

250 mcg capsule

DRUG

Placebo

Placebo pill

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Craig A. Erickson, M.D. · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2025-10-28
Completion
2026-03-05
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 NCT05418049 on ClinicalTrials.gov