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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 is a NA study that has completed, run by University of California, Davis. The registered enrollment target is 15 participants.
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.
Interventions
- DIETARY_SUPPLEMENT Sulforaphane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2023-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05233579
The ClinicalTrials.gov registry entry for NCT05233579 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sulforaphane is the first listed.
NCT05233579 reports 0 study locations.
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.
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