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NCT02460679 · ClinicalTrials.gov registry record · Phase 2

Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)

A Phase 2 study, sponsored by PTC Therapeutics.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT02460679: Completed Phase 2 study, sponsored by PTC Therapeutics.

NCT02460679 is a Phase 2 study that has completed, run by PTC Therapeutics. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02460679, a Phase 2 study, has completed, sponsored by PTC Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

This is an open label study with 30-day run in phase to establish baseline parameters, 90-day treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of treatment response, and potential effects of EPI-589 therapy on known trajectory.

Primary Outcome

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.

Interventions

  • DRUG EPI-589

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2016-01-14
Est. Completion 2018-02-23
Phase Phase 2
PTC Therapeutics

52 total trials

What the finished NCT02460679 record still lists

NCT02460679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 1 intervention - of which EPI-589 is the first listed.

NCT02460679 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02460679 about?

NCT02460679 is a clinical study titled "Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)". This is an open label study with 30-day run in phase to establish baseline parameters, 90-day treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of treatment response, and potential effects of EPI-589 therapy on known trajectory.

What is the current status of trial NCT02460679?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2016-01-14. Estimated completion is 2018-02-23.

What interventions are being tested in trial NCT02460679?

The interventions under investigation include: EPI-589 (DRUG).

Who is sponsoring clinical trial NCT02460679?

This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02460679's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 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 NCT02460679, the US trial registry maintained by the National Library of Medicine. NCT02460679 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.