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NCT05233579 · ClinicalTrials.gov registry record · NA
Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS
A NA study, sponsored by University of California, Davis.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT05233579: Completed NA study, sponsored by University of California, Davis.
NCT05233579 is a NA study that has completed, run by University of California, Davis. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05233579, a NA study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
FXTAS is a rare genetic progressive neurodegenerative disorder, linked to a trinucleotide repeat expansion in the FMR1 gene. FXTAS is characterized by tremor and ataxia in addition to atrophy and white matter disease in the central nervous system (CNS). In addition to the major clinical observations of intention tremor and gait dysfunction, minor symptoms of parkinsonism, neuropathy, and cognitive decline also significantly impact individuals with FXTAS. The dietary supplement being tested in this study is called Sulforaphane. It is found in broccoli and similar cruciferous vegetables and may cause some gas and discomfort. This is not a study looking at clinical efficacy but instead a study of molecular outcome measures. Investigators want to get more information about how Sulforaphane affects specific biomolecular markers captured in blood. In this study, participants will be taking an increasing amount of the Sulphoraphane supplement pills (238mg/tablet), starting at 1 and increasing to 6, every morning at breakfast for 6 months. In addition, there will be a total of 3 visits (Initial, 3-month and 6-month) to the MIND Institute where participants will be evaluated. At each visit (3 total) participants will undergo a battery of medical and neurologic exams which make take 2-3 days to complete each time. Participants and/or their caregivers will also be asked to fill out questionnaires/surveys. At the initial visit and at 6 months, we will collect blood for analysis. Two MRI scans will be done, also at the initial visit and at 6 months.
Primary Outcome
Primary measures are performed on PBMCs. Mitochondrial mass and membrane potential will use selected floors and either plate readers or analytical flow cytometry.
Interventions
- DIETARY_SUPPLEMENT Sulforaphane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2023-01-01 |
| Phase | NA |
What the finished NCT05233579 record still lists
NCT05233579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Sulforaphane is the first listed.
NCT05233579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05233579 about?
NCT05233579 is a clinical study titled "Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS". FXTAS is a rare genetic progressive neurodegenerative disorder, linked to a trinucleotide repeat expansion in the FMR1 gene. FXTAS is characterized by tremor and ataxia in addition to atrophy and white matter disease in the central nervous system (CNS). In addition to the major clinical observations...
What is the current status of trial NCT05233579?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2021-06-25. Estimated completion is 2023-01-01.
What interventions are being tested in trial NCT05233579?
The interventions under investigation include: Sulforaphane (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05233579?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05233579's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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