NCT03400059

Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Chordate Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment will be examined in patients diagnosed with chronic migraine. The medical device system will be applied in 6 treatments at weekly intervals. The study will examine the effects on monthly headache days with moderate to severe intensity.

Detailed description

This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of a medical device. The study consists of a 4-week screening period, a 6-week treatment period (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week follow-up period. The study primarily aims at evaluating the effect of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment on monthly headache days with moderate to severe intensity.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DEVICE	Chordate System S211 in treatment mode	Chordate System S211 in treatment mode
DEVICE	Chordate System S211 in placebo mode	Chordate System S211 in placebo mode

Timeline

• Start date: 2018-03-22
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2018-01-17
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

10 sites across 2 countries: Finland, Germany