Trial Profile

An Open-Label, Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Single-Dose Of Omaveloxolone In Children ≥2 To <16 Years Of Age With Friedreich's Ataxia

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 16 Jun 2025

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At a glance

21 May 2025 Given protocol has been amended as above-1) Number of treatment arms has been changed from 4 to 7. 2) Primary endpoints has been amended.3) Planned number of patients has been changed from 20 to 35.
21 May 2025 Planned number of patients changed from 20 to 35.
08 Jul 2024 Status changed from not yet recruiting to recruiting.

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