At a glance
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Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)
In Brief
A Phase 2 clinical trial evaluating Inosine and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 48 participants across 3 sites.
Detailed Summary
This is a multi-center, 20-week study of inosine treatment. Study Objectives and Endpoints The primary objective of the study is to determine the safety and tolerability of oral administration of inosine (administered daily) dosed to moderately elevate serum urate over 20 weeks. The primary outcome measures will be 1. Safety, as measured by adverse events 2. Tolerability, defined as the ability of subjects to complete the entire 20-week study. As an exploratory objective, we will test the feasibility and utility of a smartphone application for monitoring symptoms and disease progression in patients with amyotrophic lateral sclerosis (ALS).
Study Details
Timeline
Interventions
Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.