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Phytochemical

Sulforaphane for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

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 more

Secondary study objectives

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%

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

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