NCT03465904

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Cefaly Technology · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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, as triptans are generally used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Verum Cefaly® Abortive Program device	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.
DEVICE	Sham Cefaly® Abortive Program device	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.

Timeline

• Start date: 2018-04-10
• Primary completion: 2019-01-11
• Completion: 2019-01-11
• First posted: 2018-03-14
• Last updated: 2024-12-11
• Results posted: 2019-07-01

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study