Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine

NCT05843721 | Terminated

• 1 other identifier: PM010
• Study Type: interventional
• Target: 98
• Locations: 4 countries
• Sites: 12

Brief Summary

An non controlled, long term, multi center investigation

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after approx 6 weeks of treatment.

  Change in proportion of days with headache with moderate to severe intensity compared to the four week period starting the day after the third treatment Headache days are collected in electronic diary (eDiary)

  Baseline to 6 weeks

Secondary Outcomes (6)

• To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.

  Baseline to 12 month

• To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.

  Baseline to 12 month

• Number of patients who are responders

  Baseline to 12 month

• Number of patients who decrease use of abortive medication

  Baseline to 12 month

• Mean change in Headache Impact Test (HIT-6)

  Baseline to 12 month

Study Arms (1)

KOS treatment

OTHER

Treatment with intranasal kinetic oscillation stimulation (KOS)

Device: KOS (Intranasal kinetic oscillation stimulation)

Interventions

KOS (Intranasal kinetic oscillation stimulation) DEVICE

Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.

KOS treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form;
• Male or female aged between 18 and 70 years (inclusive) at the time of providing informed consent;
• Diagnosed with chronic migraine with or without aura (≥15 headache days per month including at least 8 migraine days for more than 3 months before screening) according to the International Headache Society classification (International Classification of Headache Disorders III);
• Migraine onset before the age of 65 years;
• Reported history of migraine for at least 1 year before screening;
• Able and willing to maintain current prophylactic migraine medication regimen (if any) (no change in type, frequency or dose) from screening to at least the 6-month follow-up;
• Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate \<1% per year when used consistently and correctly) during the study.
• Unable to distinguish between migraine headache and other headache types;
• An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity.
• Nasal cavity abnormalities that prevents catheter insertion.
• A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel).
• A known allergy to polyurethane (polyurethane is used in the catheter balloon).
• Systemic diseases with manifestations in the nose.
• Previous treatment with radiation therapy to the nasal area.
• Nasal surgery performed within the last six months.

Sponsors & Collaborators

• Chordate Medical: lead

Study Sites (12)

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum

Dresden, D-01307, Germany

Location

Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz

Essen, D-45147, Germany

Location

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, D-65929, Germany

Location

Universitätsklinikum Tübingen Klinik für Neurologie

Tübingen, D-72076, Germany

Location

Shaare Zedek Medical Center, Neurology Clinics,

Jerusalem, 9103102, Israel

Location

IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee

Milan, 20149, Italy

Location

Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation

Pavia, 27100, Italy

Location

Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia

Roma, 00128, Italy

Location

IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore

Roma, 00166, Italy

Location

Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Hull Royal Infirmary, Hull University Teaching Hospital NHS Trust

Hull, HU3 2J, United Kingdom

Location

St. George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Study Officials

• Peter J Goadsby, Prof,MD,PhD

  Wellcome Foundation Building, Denmark Hill Campus King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: November 8, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); IL (1); IT (4); DE (4)