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NCT05418049 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
A Phase 2 study of Fragile X Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT05418049: Active Phase 2 study of Fragile X Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT05418049 is a Phase 2 study of Fragile X Syndrome that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 45 participants, below the 99-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05418049, a Phase 2 study of Fragile X Syndrome, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
EEG relative gamma power at rest was calculated as the percent of power in the gamma frequencies relative to the sum of power in all frequency bands, averaged across electrodes, and calculated separately at pre-dose and post-dose timepoints. To assess the impact of drug, the pre-dose relative gamma power was subtracted from post-dose relative gamma power. Higher numbers indicate more relative gamma power post-dose; lower numbers indicate more relative gamma power pre-dose.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Roflumilast
- DRUG Memantine
- DRUG Baclofen
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-09-08 |
| Est. Completion | 2026-03-05 |
| Phase | Phase 2 |
What the registry record for NCT05418049 still lists
NCT05418049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 99-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05418049 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05418049 about?
NCT05418049 is a clinical study titled "Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge". 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.
What is the current status of trial NCT05418049?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2022-09-08. Estimated completion is 2026-03-05.
What conditions does trial NCT05418049 study?
This clinical trial studies the following conditions: Fragile X Syndrome.
What interventions are being tested in trial NCT05418049?
The interventions under investigation include: Placebo (DRUG), Roflumilast (DRUG), Memantine (DRUG), Baclofen (DRUG).
Who is sponsoring clinical trial NCT05418049?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05418049 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fragile X Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05418049's enrollment target sits among peer trials
45 11th of 16 higher than 6 of 16 other Fragile X Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fragile X Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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