CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 607 enrolled
Drug / intervention
Verum Cefaly® Abortive Program device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03465904
NCT03465904N/ACompleted
CompareCT.gov

A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)

Cefaly Technology·interventional·Posted Mar 14, 2018·Updated Dec 11, 2024

In Brief

A clinical study evaluating Verum Cefaly® Abortive Program device and Sham Cefaly® Abortive Program device for Migraine. Completed, enrolled 607 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 14, 2018
Enrollment StartApr 10, 2018
Primary CompletionJan 11, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.3 years ago

Interventions

Verum Cefaly® Abortive Program devicedevice

The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.

Sham Cefaly® Abortive Program devicedevice

The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.