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NCT02245568 · ClinicalTrials.gov registry record · Phase 3

Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

A Phase 3 study, sponsored by TauRx Therapeutics.

Terminated
Registry status
Phase 3
Development phase
913
Enrollment target

NCT02245568: Clinical Trial Phase 3 study, sponsored by TauRx Therapeutics.

NCT02245568 is a Phase 3 study that was terminated before completion, run by TauRx Therapeutics. The registered enrollment target is 913 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02245568, a Phase 3 study, was terminated before completion, sponsored by TauRx Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
913 participants
Enrollment target

Study Summary

The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.

Primary Outcome

Study-emergent adverse events (including the onset of new adverse events or worsening of pre-existing adverse events) were recorded from the time of first dose in this study to the end of study participation. All laboratory test, vital sign, or electrocardiogram parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.

Interventions

  • DRUG LMTM

Trial Details

FieldValue
Enrollment Target 913 participants
Start Date 2014-08
Est. Completion 2017-05
Phase Phase 3
TauRx Therapeutics

5 total trials

Why NCT02245568 stopped before completion

NCT02245568 is an interventional study that assigns participants to a tested intervention. The registered 913 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).

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

NCT02245568 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02245568 about?

NCT02245568 is a clinical study titled "Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)". The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.

What is the current status of trial NCT02245568?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 913 participants. The study started on 2014-08. Estimated completion is 2017-05.

What interventions are being tested in trial NCT02245568?

The interventions under investigation include: LMTM (DRUG).

Who is sponsoring clinical trial NCT02245568?

This trial is sponsored by TauRx Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02245568's enrollment target sits among peer trials

913 347th of 2000 higher than 1,654 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 NCT02245568, the US trial registry maintained by the National Library of Medicine. NCT02245568 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.