NCT04890808

Therapeutic Antioxidant Supplementation

Therapeutic Antioxidant Supplementation for Enhancement of Neural Protection From Free-iron Toxicity in Superficial Siderosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Superficial Siderosis Research Alliance Inc. · Academic / Other
• Sex: All
• Age: 16 Years – 77 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Superficial Siderosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-01
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2021-05-18
• Last updated: 2022-05-05