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Phytochemical
Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS
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
No Placebo-Only Group
Summary
This trial tests a broccoli-derived supplement called Sulforaphane on people with a rare genetic disorder causing tremors and balance issues. Participants will take the supplement for several months to see how it affects their health. The study includes various health check-ups and surveys to gather data. Sulforaphane is an antioxidant derived from broccoli sprout extracts that has been studied for its potential benefits in treating autism spectrum disorder (ASD).
Eligible Conditions
- FXTAS
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Changes in FLAIR hypersensitivity volume for subcortical lesions
Changes in Grip Strength
Changes in Hippocampus-mediated memory deficits
+15 moreSide effects data
From 2013 Phase 2 trial • 20 Patients • NCT0122808435%
Flatulence
35%
Nausea
20%
Bloating
20%
Diarrhea
20%
Dyspepsia
15%
Gatrointestinal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sulpforaphane
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~550
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
945 Previous Clinical Trials
4,756,125 Total Patients Enrolled
1 Trials studying FXTAS
20 Patients Enrolled for FXTAS