drugset / Trial / NCT01978366

Open Label Extension Study of HT-100 in Patients With DMD

NCT01978366 ↗

Phase 2 Terminated 17 enrolled Processa Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to provide 6-months continuous dosing with the study medication, called HT-100, on participants who successfully completed the predecessor study (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability, pharmacodynamic activity (testing the drug's effect on DMD) and population pharmacokinetics (measuring how much drug is in the bloodstream) in participants with a broad spectrum of Duchenne muscular dystrophy (DMD).

Timeline

Start
2013-10
Primary completion
2016-04-30
Completion
2016-04-30

Outcome

Outcome not reported

Stopped: “Dosing stopped”

Drugs

EvaluationDrugModalityDoseRoute
Subject halofuginone Small molecule — —