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HALO-DMD-02: An Open Label Extension Study of HT-100 in Patients with Duchenne Muscular Dystrophy who have Completed Protocol HALO-DMD-01
This open-label, multiple dose extension study is designed to evaluate the safety, tolerability, pharmacodynamic signals, and population PK of HT-100, a delayed-release, orally-delivered agent in participants with DMD. Study subjects will have completed Protocol HALO-DMD-01. To avoid an interruption in dosing, each consented participant will undergo the screening assessments at the time of the Month 1 Follow-up/Exit Visit of the predecessor trial, HALO-DMD-01. Participants who fulfill all eligibility criteria will be entered into the extension protocol that same day and will resume dosing with HT-100 at the same dose level as previously assigned in HALO-DMD-01. This extension study is designed to provide data on continuous, chronic (6 months) dosing. Data from this study will be subsequently used to inform the safety, tolerability, and dose selection for a future trial of HT-100 in boys with DMD. Travel assistance is available.