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

NCT03400059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-01-06

Study results available
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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.

Conditions

  • Chronic Migraine

Interventions

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

Sponsors & Collaborators

  • Vinnova

    collaborator OTHER_GOV

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Chordate Medical

    lead INDUSTRY

Principal Investigators

  • Arne May, Prof. Dr. · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • Finland
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400059 on ClinicalTrials.gov