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NCT04308954 · ClinicalTrials.gov registry record · Phase 1
Neuroimaging GABA Physiology in Fragile X Syndrome
A Phase 1 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04308954: Clinical Trial Phase 1 study, sponsored by Stanford University.
NCT04308954 is a Phase 1 study that was terminated before completion, run by Stanford University. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04308954, a Phase 1 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The investigators wish to compare the brain distribution of GABA(A) receptors and GABA levels in young adult males with Fragile X Syndrome compared to idiopathic intellectual developmental disorder. The radiopharmaceutical \[18F\]flumazenil has been used to study GABA(A) receptor distribution in other genetic syndromes with autistic features; however, despite overwhelming evidence supporting the importance of the GABAergic system in FXS, no clinical investigation of this system in human FXS has been reported in the literature. Therefore, this study will provide the first in vivo comprehensive examination of the GABAergic system in FXS using hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI).
Primary Outcome
Binding potential provides an estimate of the GABA (A) receptor distribution and affinity of \[18F\]flumazenil-PET to the GABA receptors. Binding potential will be measured in patients with fragile X syndrome and control group comprising individuals with idiopathic intellectual developmental disorder. Using imaging data obtained from PET that was corrected for attenuation and partial volume effects by MRI, nuclear medicine physicians will draw regions of interest (ROI's) around the areas of the
Interventions
- DRUG [18F]flumazenil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2018-12-06 |
| Phase | Phase 1 |
Why NCT04308954 stopped before completion
NCT04308954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]flumazenil is the first listed.
NCT04308954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04308954 about?
NCT04308954 is a clinical study titled "Neuroimaging GABA Physiology in Fragile X Syndrome". The investigators wish to compare the brain distribution of GABA(A) receptors and GABA levels in young adult males with Fragile X Syndrome compared to idiopathic intellectual developmental disorder. The radiopharmaceutical \[18F\]flumazenil has been used to study GABA(A) receptor distribution in oth...
What is the current status of trial NCT04308954?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2016-11-01. Estimated completion is 2018-12-06.
What interventions are being tested in trial NCT04308954?
The interventions under investigation include: [18F]flumazenil (DRUG).
Who is sponsoring clinical trial NCT04308954?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04308954's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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