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NCT01462292 · ClinicalTrials.gov registry record · Phase 2

A Clinical Study to Assess Two Doses of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD)

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target

NCT01462292: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01462292 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01462292, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target

Study Summary

The purpose of this study is to determine if GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping. Two doses of GSK2402968 and placebo will be used in this study.

Primary Outcome

The participants during this assessment were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in meters. Change from Baseline, was defined as the post-randomization value minus

Interventions

  • DRUG GSK2402968 3mg/kg/week
  • DRUG GSK2402968 6 mg/kg/week
  • DRUG Placebo to match GSK2402968 3 mg/kg/week
  • DRUG Placebo to match GSK2402968 6 mg/kg/week

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2011-10-26
Est. Completion 2013-11-04
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01462292 record still lists

NCT01462292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 4 interventions - of which GSK2402968 3mg/kg/week is the first listed.

NCT01462292 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01462292 about?

NCT01462292 is a clinical study titled "A Clinical Study to Assess Two Doses of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD)". The purpose of this study is to determine if GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping. Two doses of GSK2402968 and placebo will be used in this study.

What is the current status of trial NCT01462292?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2011-10-26. Estimated completion is 2013-11-04.

What interventions are being tested in trial NCT01462292?

The interventions under investigation include: GSK2402968 3mg/kg/week (DRUG), GSK2402968 6 mg/kg/week (DRUG), Placebo to match GSK2402968 3 mg/kg/week (DRUG), Placebo to match GSK2402968 6 mg/kg/week (DRUG).

Who is sponsoring clinical trial NCT01462292?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01462292's enrollment target sits among peer trials

51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01462292, the US trial registry maintained by the National Library of Medicine. NCT01462292 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.