NCT01978366

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

An Open Label Extension Study of HT-100 in Patients With Duchenne Muscular Dystrophy Who Have Completed Protocol HALO-DMD-01

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Processa Pharmaceuticals · Industry
• Sex: Male
• Age: 6 Years – 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	HT-100	May be administered in either fed or fasted state

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-04-30
• Completion: 2016-04-30
• First posted: 2013-11-07
• Last updated: 2020-09-03

Locations

5 sites across 1 country: United States