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NCT03465904 · ClinicalTrials.gov registry record · NA

A Phase III Trial of e-TNS for the Acute Treatment of Migraine

A NA study of Migraine, sponsored by Cefaly Technology.

Completed
Registry status
NA
Development phase
607
Enrollment target
10
Study locations

NCT03465904: Completed NA study of Migraine, sponsored by Cefaly Technology.

NCT03465904 is a NA study of Migraine that has completed, run by Cefaly Technology. The registered enrollment target is 607 participants, above the 352-participant average among 102 other Migraine trials with a reported enrollment target (72% higher). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03465904, a NA study of Migraine, has completed, sponsored by Cefaly Technology.

COMPLETED
Registry status
NA
Development phase
607 participants
Enrollment target
10
Study locations

Study Summary

The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.

Primary Outcome

The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.

Conditions Studied

Interventions

  • DEVICE Verum Cefaly® Abortive Program device
  • DEVICE Sham Cefaly® Abortive Program device

Study Locations (10)

Arizona

  • Clinical Research Consortium - Tempe

California

  • Pharmacology Research Institute - Encino

Connecticut

  • Yale University - New Haven

Florida

  • Palm Beach Research Center - West Palm Beach

Georgia

  • Meridian Clinical Research (Savannah Neurology) - Savannah

Maryland

  • Meridian Clinical Research (Rockville Neurology) - Rockville

Nevada

  • Clinical Research Consortium - Las Vegas

New York

  • Rochester Clinical Research - Rochester

Trial Details

FieldValue
Enrollment Target 607 participants
Start Date 2018-04-10
Est. Completion 2019-01-11
Phase NA
Cefaly Technology

7 total trials

What the finished NCT03465904 record still lists

NCT03465904 is an interventional study that assigns participants to a tested intervention. The registered 607 participants enrollment target is mid-sized for trials with a published cap, above the 352-participant average among 102 other Migraine trials with a reported enrollment target (72% higher).

The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Verum Cefaly® Abortive Program device is the first listed.

NCT03465904 lists 10 locations in 10 states (Arizona, California, Connecticut).

Frequently Asked Questions

What is clinical trial NCT03465904 about?

NCT03465904 is a clinical study titled "A Phase III Trial of e-TNS for the Acute Treatment of Migraine". The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Pr...

What is the current status of trial NCT03465904?

This trial is currently completed. It is a NA study. The enrollment target is 607 participants. The study started on 2018-04-10. Estimated completion is 2019-01-11.

What conditions does trial NCT03465904 study?

This clinical trial studies the following conditions: Migraine.

What interventions are being tested in trial NCT03465904?

The interventions under investigation include: Verum Cefaly® Abortive Program device (DEVICE), Sham Cefaly® Abortive Program device (DEVICE).

Who is sponsoring clinical trial NCT03465904?

This trial is sponsored by Cefaly Technology, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03465904 being conducted?

This trial has 10 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Migraine

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03465904's enrollment target sits among peer trials

607 16th of 102 higher than 87 of 102 other Migraine trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Migraine 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 NCT03465904, the US trial registry maintained by the National Library of Medicine. NCT03465904 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.