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Phytochemical

Sulforaphane for Fragile X Syndrome

N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights

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.

Eligible Conditions
  • Fragile X Associated Tremor/Ataxia Syndrome (FXTAS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in mitochondrial function via ATP production
Changes in mitochondrial function via mitochondrial membrane potential and mass.
Observing changes in candidate molecular biomarkers in FXTAS and mitochondrial dysregulation: Bax/Bcl-2 ratio
+2 more
Secondary outcome measures
Changes in FLAIR hypersensitivity volume for subcortical lesions
Changes in Grip Strength
Changes in Hippocampus-mediated memory deficits
+15 more

Side effects data

From 2013 Phase 2 trial • 20 Patients • NCT01228084
35%
Flatulence
35%
Nausea
20%
Bloating
20%
Diarrhea
20%
Dyspepsia
15%
Gatrointestinal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sulpforaphane

Trial Design

6Treatment groups
Experimental Treatment
Group I: Sulforaphane 5 TabletsExperimental Treatment1 Intervention
Participants will increase dosage to 5 tablets per day at 8 weeks from the start of study participation. Participants will continue to take 5 tablets for 2 addiitonal weeks before increasing dose. If participants experience adverse side effects, participants will decrease dosage to 4 tablets.
Group II: Sulforaphane 4 TabletsExperimental Treatment1 Intervention
Participants will increase dosage to 4 tablets per day at 6 weeks from the start of study participation. Participants will continue to take 4 tablets for 2 addiitonal weeks before increasing dose. If participants experience adverse side effects, participants will decrease dosage to 3 tablets.
Group III: Sulforaphane 3 TabletsExperimental Treatment1 Intervention
Participants will increase dosage to 3 tablets per day at 4 weeks from the start of study participation. Participants will continue to take 3 tablets for 2 addiitonal weeks before increasing dose. If participants experience adverse side effects, participants will decrease dosage to 2 tablets.
Group IV: Sulforaphane 2 TabletsExperimental Treatment1 Intervention
Participants will increase dosage to 2 tablets per day after 2 weeks from the start of study participation. Participants will continue to take 2 tablets for 2 addiitonal weeks before increasing dose. If participants experience adverse side effects, participants will decrease dosage to 1 tablet.
Group V: Sulforaphane 1 TabletExperimental Treatment1 Intervention
Participants are taking 1 tablet per day. All participants will start with 1 tablet and continue with 1 tablet for 2 weeks before increasing dose.
Group VI: SulforaphaneExperimental Treatment1 Intervention
Participants will increase dosage to 6 tablets per day at 10 weeks from the start of study participation. Participants will continue to take 6 tablets for 2 addiitonal weeks before increasing dose. If participants experience adverse side effects, participants will decrease dosage to 5 tablets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulforaphane
2016
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
908 Previous Clinical Trials
4,704,100 Total Patients Enrolled
6 Trials studying Fragile X Syndrome
449 Patients Enrolled for Fragile X Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025