NCT03217968

Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Cefaly Technology · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.

Detailed description

The main objective of this study is to have a pilot assessment 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 pilot data to assess the efficacy 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	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).

Timeline

• Start date: 2017-08-10
• Primary completion: 2018-01-10
• Completion: 2018-01-10
• First posted: 2017-07-14
• Last updated: 2018-08-07
• Results posted: 2018-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study