At a glance
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A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Neurological Effects of EryDex on Subjects With Ataxia Telangiectasia (NEAT)
In Brief
A Phase 3 clinical trial evaluating Dexamethasone sodium phosphate and Placebo for Ataxia Telangiectasia. Completed, enrolled 105 participants across 19 sites in 9 countries.
Detailed Summary
This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate \[DSP\] in autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangiectasia (A-T).
Study Details
Timeline
Interventions
Dexamethasone sodium phosphate encapsulated in autologous erythrocytes and administered via IV infusion
Placebo encapsulated in autologous erythrocytes and administered via IV infusion