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Completed Phase 3 Interventional

Study of Ataluren in Previously Treated Participants With Nonsense Mutation Dystrophinopathy (nmDBMD)

ClinicalTrials.gov ID: NCT01247207

Public ClinicalTrials.gov record NCT01247207. 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 Sep 8, 2026, 11:57 PM 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, Safety Study for Ataluren (PTC124) Patients With Nonsense Mutation Dystrophinopathy

Brief summary

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

The objective of this study is to assess the safety and tolerability of 10, 10, 20 milligrams per kilogram (mg/kg) ataluren in participants with nmDBMD who had prior exposure to ataluren in a PTC sponsored clinical trial or treatment plan, and siblings of those participants (provided those participants have completed the placebo-controlled portion of the trial). The treatment will continue under this protocol until consent withdrawal by participants, withdrawal due to worsen condition after initiating ataluren treatment, withdrawal by investigator, withdrawal due to participant unable to tolerate ataluren, participant is eligible to participate in another ataluren nmDBMD clinical trial program initiated by sponsor, study is discontinued by the relevant regulatory authority and/or sponsor, or until ataluren becomes commercially available.

Study identification

NCT ID
NCT01247207
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
PTC Therapeutics
Industry
Enrollment
270 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
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
Nov 29, 2010
Primary completion
Feb 9, 2026
Completion
Feb 9, 2026
Last update posted
Mar 8, 2026

2010 – 2026

United States locations

U.S. sites
29
U.S. states
21
U.S. cities
28
Facility City State ZIP Site status
Phoenix Childrens Hospital Phoenix Arizona 85016
Children's Hospital of Los Angeles Los Angeles California 90027
UCLA Los Angeles California 90095
Stanford University Palo Alto California 94304
University of California-Davis Sacramento California 95817
University of CA, San Francisco-Benioff Children's Hospital San Francisco California 94158
Children's Hospital Colorado - Center for Cancer and Blood Disorders Aurora Colorado 80045
Child Neurology Center of NW Florida NW Gulf Breeze Florida 32561
Rare Disease Research, LLC Atlanta Georgia 30329
Rush Univ Medical Center Chicago Illinois 60612
University of Iowa Children's Hospital Iowa City Iowa 52242
University of Kansas Medical Center Kansas City Kansas 66160
Children's Hospital of Boston/Harvard Medical School Boston Massachusetts 02115
University of Michigan Ann Arbor Michigan 48109
University of Minnesota Minneapolis Minnesota 55455
Washington University Medical School St Louis Missouri 63110
Columbia University Pediatric Neuromuscular Center New York New York 10032
Duke University Medical Center Durham North Carolina 27710
Cincinnati Childrens Hospital Medical Center Cincinnati Ohio 45229
Nationwide Children's Hospital Columbus Ohio 43205
Shriners Hospital for Children-Portland Portland Oregon 97239
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 16148
Childrens Medical Center Dallas Dallas Texas 75207
Texas Children's Hospital Houston Texas 77030
University of Texas Health Science Center at San Antonio San Antonio Texas 78229
University of Utah Salt Lake City Utah 84112
Children's Hospital of the King's Daughters Norfolk Virginia 23507
Seattle Children's Hospital Seattle Washington 98105

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01247207, 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 Mar 8, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01247207 live on ClinicalTrials.gov.

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