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Terminated Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01978366

Public ClinicalTrials.gov record NCT01978366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 9:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01978366
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Processa Pharmaceuticals
Industry
Enrollment
17 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 20 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2013 (Actual)
Primary completion
Apr 30, 2016 (Actual)
Completion
Apr 30, 2016 (Actual)
Last update posted
Sep 3, 2020

2013 – 2016

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
University of California, Davis Medical Center Sacramento California 95817 —
Kennedy Krieger Institute, Johns Hopkins School of Medicine Baltimore Maryland 21205 —
Washington University School of Medicine St Louis Missouri 63110 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Nationwide Children's Hospital Columbus Ohio 43205 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01978366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2020 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01978366 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →