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Therapeutic Antioxidant Supplementation

NCT04890808 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-05

No results posted yet for this study

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.

Conditions

  • Superficial Siderosis

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

Sponsors & Collaborators

  • Superficial Siderosis Research Alliance Inc.

    lead OTHER

Principal Investigators

  • Rori-Suzanne Daniel · Superfical Siderosis Research Alliance

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2027-06-30
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890808 on ClinicalTrials.gov