NCT02185703

Chordate System S020 Acute Migraine Clinical Investigation

A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Chordate Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.

Detailed description

One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode. After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.

Conditions

• Acute Migraine

Interventions

Type	Name	Description
DEVICE	Chordate System S020 in treatment mode
DEVICE	Chordate System S020 in placebo mode

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-07-09
• Last updated: 2015-08-05

Locations

9 sites across 1 country: Germany