Study Summary
This trial is testing a dietary supplement called Sulforaphane to see if it affects specific biomolecular markers captured in blood. Participants take increasing doses of the supplement over 6 months and have 3 medical evaluations.
- Fragile X Associated Tremor/Ataxia Syndrome (FXTAS)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 18 Secondary · Reporting Duration: Baseline, 6 months
Trial Safety
Safety Progress
Side Effects for
Trial Design
6 Treatment Groups
Sulforaphane 2 Tablets
1 of 6
Sulforaphane 4 Tablets
1 of 6
Sulforaphane 5 Tablets
1 of 6
Sulforaphane 1 Tablet
1 of 6
Sulforaphane
1 of 6
Sulforaphane 3 Tablets
1 of 6
Experimental Treatment
15 Total Participants · 6 Treatment Groups
Primary Treatment: Sulforaphane · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 50 - 85 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Napoli, Eleonora, Amanda Flores, Yasmeen Mansuri, Randi J. Hagerman, and Cecilia Giulivi. 2021. “Sulforaphane Improves Mitochondrial Metabolism in Fibroblasts from Patients with Fragile X-associated Tremor and Ataxia Syndrome”. Neurobiology of Disease. Elsevier BV. doi:10.1016/j.nbd.2021.105427.
- Berry-Kravis, Elizabeth M., Mark D. Harnett, Scott A. Reines, Melody A. Reese, Lauren E. Ethridge, Abigail H. Outterson, Claire Michalak, Jeremiah Furman, and Mark E. Gurney. 2021. “Inhibition of Phosphodiesterase-4d in Adults with Fragile X Syndrome: A Randomized, Placebo-controlled, Phase 2 Clinical Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01321-w.
- Uddin, Md. Sahab, Abdullah Al Mamun, Md. Jakaria, Shanmugam Thangapandiyan, Jamil Ahmad, Md. Ataur Rahman, Bijo Mathew, Mohamed M. Abdel-Daim, and Lotfi Aleya. 2020. “Emerging Promise of Sulforaphane-mediated Nrf2 Signaling Cascade Against Neurological Disorders”. Science of the Total Environment. Elsevier BV. doi:10.1016/j.scitotenv.2019.135624.
- Uddin MS, Mamun AA, Jakaria M, Thangapandiyan S, Ahmad J, Rahman MA, Mathew B, Abdel-Daim MM, Aleya L. Emerging promise of sulforaphane-mediated Nrf2 signaling cascade against neurological disorders. Sci Total Environ. 2020 Mar 10;707:135624. doi: 10.1016/j.scitotenv.2019.135624. Epub 2019 Nov 21.
- 2021. "Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233579.
Frequently Asked Questions
What is the current enrollment tally for participants in this trial?
"Affirmative. According to the clinicaltrials.gov database, this trial is currently searching for suitable participants. This research was initially posted on June 25th 2021 and has been revised as recently as January 31st 2022. The researchers are looking to recruit 15 individuals from one specific site." - Anonymous Online Contributor
What are the primary goals of this research initiative?
"The principal objective of this medical trial, tracked across Baseline and 6 months, is to ascertain any fluctuations in mitochondrial function through the production of Adenosine Triphosphate (ATP). Other secondary outcomes being measured include changes in kinetic, postural and rest tremor upper extremity bradykinesia/hypokinesia/dysrhythmia/dyskinesias as quantified by pre-ordained Kinesia One tests; alterations in Fragile X Tremor Ataxia Syndrome (FXTAS) clinical staging via a standardised neurological examination;; plus shifts occurring within subcortical brain" - Anonymous Online Contributor
Is the elderly population allowed to partake in this experiment?
"The age range for acceptance into this trial is between 50 and 85 years old." - Anonymous Online Contributor
Are there any vacancies available within this research project?
"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is presently recruiting participants, having been first publicized on June 25th 2021 and most recently amended on January 31st 2022. The investigators are seeking 15 patients from one site to take part in the study." - Anonymous Online Contributor
May I partake in this research endeavor?
"This research study seeks to recruit 15 individuals with ataxia in the ages of 50-85. All applicants should satisfy two key considerations: A diagnosis of FXTAS and a FMR1 premutation (55 to 200 CGG repeats)." - Anonymous Online Contributor