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NCT02090959 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy
A Phase 3 study, sponsored by PTC Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT02090959: Clinical Trial Phase 3 study, sponsored by PTC Therapeutics.
NCT02090959 is a Phase 3 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02090959, a Phase 3 study, was terminated before completion, sponsored by PTC Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study Summary
The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren \[PTC124-GD-020-DMD {NCT01826487}\]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study. This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.
Primary Outcome
An adverse event (AE): any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of AEs: graded per Common Terminology Criteria for AEs (CTCAE), Version 3.0 as Grade 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). Drug-related AEs: AEs with possible, probable, unlikely relationship, or unrelated to study drug. Serious AEs (SAEs): death, a life-threatening AE, inpatient hospitalization or prolongati
Interventions
- DRUG Ataluren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2014-03-20 |
| Est. Completion | 2018-06-12 |
| Phase | Phase 3 |
Why NCT02090959 stopped before completion
NCT02090959 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Ataluren is the first listed.
NCT02090959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02090959 about?
NCT02090959 is a clinical study titled "An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy". The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren \[PTC124-GD-020-DMD {NCT01826487}\]) to augment the overall safety database. Screening ...
What is the current status of trial NCT02090959?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2014-03-20. Estimated completion is 2018-06-12.
What interventions are being tested in trial NCT02090959?
The interventions under investigation include: Ataluren (DRUG).
Who is sponsoring clinical trial NCT02090959?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02090959's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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