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Therapeutic Antioxidant Supplementation
Sponsor: Superficial Siderosis Research Alliance Inc.
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.
Official title: Therapeutic Antioxidant Supplementation for Enhancement of Neural Protection From Free-iron Toxicity in Superficial Siderosis
Key Details
Gender
All
Age Range
16 Years - 77 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-05
Completion Date
2027-09
Last Updated
2022-05-05
Healthy Volunteers
No
Conditions
Interventions
Inosine
Patients will be dosed with two 500 mg capsules of Inosine twice daily for 36 months
IP6
Patients will be dosed with two 500 mg capsules of IP6 twice daily for 36 months