Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS
Fragile X Associated Tremor/Ataxia Syndrome (Fxtas) (Diagnosis)
About this trial
This is an interventional basic science trial for Fragile X Associated Tremor/Ataxia Syndrome (Fxtas) (Diagnosis) focused on measuring Sulforaphane
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of FXTAS
- Presence of a FMR1 premutation (55 to 200 CGG repeats)
Exclusion Criteria:
- Individuals with severe renal failure (GFR is <60 ml/min/1.73 m^2)
- Significant and current reported substance abuse
- Individuals with substance use disorder (meets 6 or more symptoms of substance use disorder criteria)
- Any subject on hospice or on home oxygen
- Individuals who are pregnant
Sites / Locations
- UC Davis MIND Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Sulforaphane 1 Tablet
Sulforaphane 2 Tablets
Sulforaphane 3 Tablets
Sulforaphane 4 Tablets
Sulforaphane 5 Tablets
Sulforaphane
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.
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.
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.
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.
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.
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.