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NCT02160535 · ClinicalTrials.gov registry record · Phase 3

Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

A Phase 3 study, sponsored by University of Washington.

Terminated
Registry status
Phase 3
Development phase
13
Enrollment target

NCT02160535: Clinical Trial Phase 3 study, sponsored by University of Washington.

NCT02160535 is a Phase 3 study that was terminated before completion, run by University of Washington. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02160535, a Phase 3 study, was terminated before completion, sponsored by University of Washington.

TERMINATED
Registry status
Phase 3
Development phase
13 participants
Enrollment target

Study Summary

This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.

Primary Outcome

To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).

Interventions

  • DRUG OnabotulinumtoxinA

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2014-05
Est. Completion 2016-08
Phase Phase 3
University of Washington

1,048 total trials

Why NCT02160535 stopped before completion

NCT02160535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

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

NCT02160535 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02160535 about?

NCT02160535 is a clinical study titled "Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA". This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor ...

What is the current status of trial NCT02160535?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2014-05. Estimated completion is 2016-08.

What interventions are being tested in trial NCT02160535?

The interventions under investigation include: OnabotulinumtoxinA (DRUG).

Who is sponsoring clinical trial NCT02160535?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02160535's enrollment target sits among peer trials

13 1984th of 2000 higher than 17 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 NCT02160535, the US trial registry maintained by the National Library of Medicine. NCT02160535 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.