NCT02243865

Chordate System Prophylactic Migraine Clinical Investigation

A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Chordate Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine.

Detailed description

This was a prospective, interventional, randomized, placebo-controlled, double-blind, multi-center clinical investigation of a medical device system. A pilot study in which patients with frequent migraine attacks received intranasal KOS or placebo using the Chordate System S200 on two occasions.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Chordate System S200 + CT100 (active treatment)	Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).
DEVICE	Chordate System S200 + CT100 (placebo treatment)	Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2014-09-18
• Last updated: 2021-11-08
• Results posted: 2021-11-08

Locations

4 sites across 1 country: Sweden