Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

Inclusion Criteria

Diagnosis of FXTAS

Presence of a FMR1 premutation (55 to 200 CGG repeats)

Exclusion Criteria

You have a serious and ongoing problem with drug or alcohol abuse.

You are currently pregnant.

You have a drug or alcohol addiction, as determined by showing six or more symptoms of substance use disorder.

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Treatment Details

Interventions

Sulforaphane (Phytochemical)

Participant Groups

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.