Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 15 participants
Start Date 2021-06-25
Est. Completion 2023-01-01
Phase NA

Sponsor

University of California, Davis

657 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.