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NCT01208129 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

A Phase 3 study, sponsored by Promius Pharma.

Terminated
Registry status
Phase 3
Development phase
458
Enrollment target

NCT01208129: Clinical Trial Phase 3 study, sponsored by Promius Pharma.

NCT01208129 is a Phase 3 study that was terminated before completion, run by Promius Pharma. The registered enrollment target is 458 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01208129, a Phase 3 study, was terminated before completion, sponsored by Promius Pharma.

TERMINATED
Registry status
Phase 3
Development phase
458 participants
Enrollment target

Study Summary

The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Interventions

  • DRUG Placebo control
  • DRUG NAB001

Trial Details

FieldValue
Enrollment Target 458 participants
Start Date 2010-09
Est. Completion 2012-07
Phase Phase 3
Promius Pharma

9 total trials

Why NCT01208129 stopped before completion

NCT01208129 is an interventional study that assigns participants to a tested intervention. The registered 458 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 (41% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.

NCT01208129 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01208129 about?

NCT01208129 is a clinical study titled "Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails". The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

What is the current status of trial NCT01208129?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 458 participants. The study started on 2010-09. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01208129?

The interventions under investigation include: Placebo control (DRUG), NAB001 (DRUG).

Who is sponsoring clinical trial NCT01208129?

This trial is sponsored by Promius Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01208129's enrollment target sits among peer trials

458 827th of 2000 higher than 1,174 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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Source: ClinicalTrials.gov NCT01208129, the US trial registry maintained by the National Library of Medicine. NCT01208129 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.