Therapeutic Antioxidant Supplementation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inosine, IP6.
- Who it may be relevant to
- Registry conditions: Superficial Siderosis. Basic parameters: 16 years — 77 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Therapeutic Antioxidant Supplementation for Enhancement of Neural Protection From Free-iron Toxicity in Superficial Siderosis
Overview
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 therapy to combat or slow neural damage progression either concurrently with existing iron chelation therapy or during the natural course of the disorder. Clinical changes in hearing, balance, and mobility, and cognition will be assessed for 36 months through patient-reported outcomes of study assigned assessments.
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 screening will determine patient arm assignment.
Before dosing begins, patients will submit copies of previous audiogram results (3yrs), radiology reports (3yrs), and MRI series (3yrs) if available and complete baseline assessment activities: Montreal Cognitive Assessment (MoCA) administered remotely, Timed Up, and Go (TUG), 2-Minute Walk Test (2-MWT), The Activities-specific Balance Confidence (ABC) Scale, iSS-QoL (custom) patient outcome reported
Assessment will take place four times: baseline, end-of-year 1 (12mo), end-of-year 2 (24mo), end-of-study (36mo).
Interventions
- Dietary supplement Inosine
Patients will be dosed with two 500 mg capsules of Inosine twice daily for 36 months - Dietary supplement IP6
Patients will be dosed with two 500 mg capsules of IP6 twice daily for 36 months
Primary outcome measures
- Slow the Rate of Clinical Decline [Time frame: 36 Months]
Secondary outcome measures (6)
- Clinical Efficacy: Rate of Adverse Event Development [Safety and Tolerability} [Time frame: 36 Months]
- Clinical Efficacy: Improved Quality of Life [Time frame: 36 Months]
- Clinical Efficacy: Rate of Change in Montreal Cognitive Assessment (MoCA) [Time frame: 36 Months]
- Clinical Efficacy: Rate of Change in Hearing [Time frame: 36 Months]
- Clinical Efficacy: Rate of Change in Mobility and Balance [Time frame: 36 Months]
- Clinical Efficacy: Hemosiderin Reduction (IP6 Arm) [Time frame: 36 Months]
Eligibility criteria
Inclusion criteria
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 criteria
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04890808 · SSRA0921