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NCT02819557 · ClinicalTrials.gov registry record · Phase 2
Study of Ataluren in ≥2 to <5 Year-Old Male Participants With Duchenne Muscular Dystrophy
A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 6
- Study locations
NCT02819557 is a Phase 2 study of Duchenne Muscular Dystrophy that has completed, run by PTC Therapeutics. The registered enrollment target is 14 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT02819557, a Phase 2 study of Duchenne Muscular Dystrophy, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a Phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ataluren in participants aged ≥2 to \<5 years old with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene.
Conditions Studied
Interventions
- DRUG Ataluren
Study Locations (6)
Florida
- Child Neuro NWF - Gulf Breeze
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Children's Hospital Boston - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- Children's Medical Center Dallas - Dallas
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-06-09 |
| Est. Completion | 2018-02-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02819557
The ClinicalTrials.gov registry entry for NCT02819557 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower). The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Ataluren is the first listed.
NCT02819557 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Florida, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02819557 about?
NCT02819557 is a clinical study titled "Study of Ataluren in ≥2 to <5 Year-Old Male Participants With Duchenne Muscular Dystrophy". This is a Phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ataluren in participants aged ≥2 to \<5 years old with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene.
What is the current status of trial NCT02819557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2016-06-09. Estimated completion is 2018-02-09.
What conditions does trial NCT02819557 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT02819557?
The interventions under investigation include: Ataluren (DRUG).
Who is sponsoring clinical trial NCT02819557?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02819557 being conducted?
This trial has 6 study locations across Florida, Illinois, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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