Open Label Extension Study of HT-100 in Patients With DMD
Stopped early · Phase 2
Conditions studied: Duchenne Muscular Dystrophy
In brief
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).
Key facts
- Study ID
- NCT01978366
- Run by
- Processa Pharmaceuticals
- People needed
- 17
- Starts
- 2013-10-01
- Expected to finish
- 2016-04-30
- Last updated by the study team
- 2020-09-03
Who can join
Age: 6 and older, up to 20. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Completed both the single ascending dose (SAD) and multiple ascending dose (MAD) phases of predecessor study HALO-DMD-01
- Maintained the same corticosteroid therapy from the predecessor study HALO-DMD-01
- Ability to provide written informed consent
- Ambulatory or non-ambulatory
You may not qualify if…
- Recent, substantial change in use of cardiac medications or medications affecting muscle function
- Clinically significant major disease, not related to DMD
- Significantly compromised cardio-respiratory function
- History of severe allergic or anaphylactic reactions
- Prior treatment with another investigational product in past 6 months
- Inability to undergo magnetic resonance imaging (MRI)
- Current drug or alcohol abuse or prior treatment for abuse
Where it is running
- University of California, Davis Medical Center — Sacramento, California, United States
- Kennedy Krieger Institute, Johns Hopkins School of Medicine — Baltimore, Maryland, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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