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

NCT01978366·5 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Processa Pharmaceuticals

Age

6–20

Sex

MALE

Healthy volunteers

Not accepted

You may be eligible 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 be 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

The record

StatusTerminated

PhasePhase 2

Taking part17

StartedOct 2013

UpdatedSep 3, 2020

Conditions

Duchenne Muscular Dystrophy

Where5

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

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