Health TrialsbyHealthPanel

Therapeutic Antioxidant Supplementation

ConditionSuperficial Siderosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-77
SponsorSuperficial Siderosis Research Alliance Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inosine

    Dietary supplement

    Patients will be dosed with two 500 mg capsules of Inosine twice daily for 36 months

  • IP6

    Dietary supplement

    Patients will be dosed with two 500 mg capsules of IP6 twice daily for 36 months

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Over-the-Counter Dietary Supplement InosineExperimental treatment 1 intervention
Group B: Over-the-Counter Dietary Supplement IP6Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Slow the Rate of Clinical Decline

Deceleration of clinical decline will be quantified by evaluating three primary areas- hearing, balance and mobility, and cognition. End-of-study quantifiable slowing of the historical and year-1 mean rate of decline across all three study areas with a measurable increase on Year-3 iSS-QOL from Year-1 iSS-QOL scoring.

Time frame
36 Months

Secondary outcomes

1

Clinical Efficacy: Rate of Adverse Event Development [Safety and Tolerability}

Therapeutic use of antioxidants through a safe, effective dose range and schedule to the extent that the risk-benefit relationship is acceptable for the patient. Evaluation will include the overall adverse event (AE) and serious AE (SAE) rate.

Time frame
36 Months
2

Clinical Efficacy: Improved Quality of Life

The rate of change in points on the iSS-QoL(custom) from baseline assessment to end-of-study will be scored based on 16 questions with a point range of 1-5. Higher end-of-study scores indicate greater satisfaction.

Time frame
36 Months
3

Clinical Efficacy: Rate of Change in Montreal Cognitive Assessment (MoCA)

The rate of change in points on the Montreal Cognitive Assessment (MoCA) scale from baseline assessment to end-of-study will be assessed for patients in each treatment group. The MoCA assesses attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Points (range 0-30) are awarded for the correct completion of MoCA tasks. Cognition decline will be defined as ≥ 3pt decline of total MoCA score from baseline assessment to final 36mo testing assessment.

Time frame
36 Months
4

Clinical Efficacy: Rate of Change in Hearing

The baseline audiogram will be compared to the post-study audiogram for each patient. The hearing levels in decibels against the frequency in hertz will be compared pre-study, baseline, and end-of-study for average rate-of-decline. A paired t-test will be used to determine statistical significance in the average difference in the threshold hearing level at any particular frequency.

Time frame
36 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Superficial Siderosis Research Alliance Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: