Status:
NOT_YET_RECRUITING
Therapeutic Antioxidant Supplementation
Lead Sponsor:
Superficial Siderosis Research Alliance Inc.
Conditions:
Superficial Siderosis
Eligibility:
All Genders
16-77 years
Phase:
NA
Brief Summary
A remotely administered study, non-randomized, non-blinded, controlled parallel assignment phase 2 trial to determine if oral inosine or inositol hexaphosphate will provide an effective long-term ther...
Detailed Description
Capsules containing over-the-counter dietary supplement formulas of inosine 500 mg or 500 mg of inositol hexaphosphate(IP6) will be taken orally, two capsules two times per day for 36 months. Initial ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of iSS (superficial siderosis of the CNS)
- No illegal drug use
- No history of myocardial infarction or stroke
- No history of severe chronic obstructive pulmonary disease
- Can safely swallow large capsules
- Exhibits at least one confirmed iSS related symptom: Hearing Loss, Balance, Memory/Cognitive problems
- Does not have a known hypersensitivity or intolerance to any study antioxidant
- Has not taken part in another treatment study for any condition within the last 30 days (about four and a half weeks)
- Not currently pregnant or breastfeeding
Exclusion
- Inosine Arm Exclusion :
- Diagnosed with urate urolithiasis, or recurrent urolithiasis, all unknown type
- History of Gout
- History of Kidney Stones
- P6 Arm Exclusion
- Long-term anticoagulant
- Known or suspected active bleed into the CNS
- Currently undergoing deferiprone chelation therapy
- Plan to begin deferiprone chelation therapy within three years
- \-
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04890808
Start Date
May 1 2023
End Date
September 1 2027
Last Update
May 5 2022
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