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

StatusTerminated
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 57 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Reclassified as terminated (was completed) Sponsor's reason: Sponsor decision Show 6 more changesShow less
    • Results posted: Oct 8, 2026
    • Primary endpoints: 3 to 1
    • Enrollment target: estimated 270 to confirmed 265
    • Start date: Nov 30, 2010 to Nov 22, 2010
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 13 of 34 sites
  2. Primary and study completion dates changed from estimate of Apr 30, 2025 to Feb 10, 2026
    • Trial status: Enrolling by Invitation to Completed
    v56
  3. 3 versions Re-verified since Jan 7, 2025, no change to tracked fieldsv53-v55
  4. Study sites revised (34)v52
  5. 3 versions Re-verified since Jul 25, 2024, no change to tracked fieldsv49-v51
Show 41 earlier versionsHide 41 earlier versions
  1. Primary and study completion dates: Apr 30, 2024 to Apr 30, 2025
    • Study sites revised (34)
    v48
  2. 2 versions Re-verified since Mar 1, 2024, no change to tracked fieldsv46-v47
  3. Primary and study completion dates: Dec 15, 2023 to Apr 30, 2024v45
  4. Re-verified, no change to tracked fieldsv44
  5. Study sites: 33 to 34v43
  6. Eligibility criteria revisedv42
  7. 5 versions Re-verified since Aug 14, 2022, no change to tracked fieldsv37-v41
  8. Study sites: 31 to 33v36
  9. 2 versions Re-verified since Mar 23, 2022, no change to tracked fieldsv34-v35
  10. Study sites: 30 to 31v33
  11. Enrollment target: 160 to 270
    • Eligibility criteria expanded, about 25 words
    v32
  12. Primary completion date: Dec 15, 2021 to Dec 15, 2023
    • Study sites: 29 to 30
    v31
  13. Study completion date: Dec 15, 2021 to Dec 15, 2023v30
  14. Study sites: 28 to 29v29
  15. Re-verified, no change to tracked fieldsv28
  16. Study sites: 27 to 28v27
  17. 2 versions Re-verified since Feb 17, 2021, no change to tracked fieldsv25-v26
  18. Primary and study completion dates: Dec 31, 2020 to Dec 15, 2021v24
  19. Re-verified, no change to tracked fieldsv23
  20. Study sites: 25 to 27v22
  21. Study sites: 24 to 25v21
  22. Re-verified, no change to tracked fieldsv20
  23. Study sites: 25 to 24v19
  24. Eligibility criteria expanded, about 19 wordsv18
  25. 5 versions Re-verified since Mar 18, 2019, no change to tracked fieldsv13-v17
  26. Primary and study completion dates: Dec 31, 2018 to Dec 31, 2020
    • Study sites: 15 to 25
    v12
  27. Enrollment target: 110 to 160
    • Primary and study completion dates: Dec 2018 to Dec 31, 2018
    • Start date: Nov 2010 to Nov 30, 2010
    • Eligibility criteria expanded, about 74 words
    v11
  28. Study sites: 14 to 15v10
  29. Primary and study completion dates: Aug 2017 to Dec 2018v9
  30. Primary and study completion dates: Dec 2014 to Aug 2017v8
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01247207
Lead Sponsor PTC Therapeutics
Conditions
(from sponsor)		 Duchenne Muscular Dystrophy
Related terms Muscular Dystrophy, Duchenne
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov