A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine

NCT05273151 | Terminated

• 1 other identifier: PM009
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

An open pilot study, non-controlled, single center investigation.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Mean change in headache days

  Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary

  baseline to 6 weeks

Secondary Outcomes (8)

• Mean change in Migraine days Mean change of migraine days, responder rate, use of abortive medication, health-related quality of life and disability, and patient's global impression of severity 12 weeks (90 days)

  Baseline to 12 weeks

• Incidence of adverse events (AEs) and adverse device effects (ADEs)

  Baseline to 12 weeks

• Number of patients who are responders

  baseline to 12 weeks

• Number of patients who decrease use of abortive medication

  baseline to 12 weeks

• Mean change in Hospital Anxiety and Depression Scale (HADS)

  baseline to 12 weeks

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 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 as suffering from 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 50 years.
• Reported history of migraine for at least 1 year before screening.
• If subjects are on a preventive treatment at the time of screening, this must have been stable over the preceding 3 months.
• If subjects are on preventive treatment at the time of screening, they have to be able and willing to maintain current preventive treatment regimen (no change in type, frequency or dose) from screening to end of follow-
• Failed at least 3 different preventive medications and 3 months of treatment with a CGRP targeting therapy.
• 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.

You may not qualify if:

• Unable to distinguish between migraine 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.
• Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;
• Pregnant and lactating women;
• Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
• Previous participation in this study;
• Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals;

Sponsors & Collaborators

• Chordate Medical: lead

Study Sites (2)

Hull Royal Infirmary, Hull University Teaching Hospital

Hull, HU3 2JZ,, United Kingdom

Location

Wolfson Centre for Age-Related Diseases Institute of Psychiatry, Psychology and Neuroscience Wellcome Foundation Building, Denmark Hill Campus King's College

London, SE5 9PJ,, 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

Model Details: Open label Investigation

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 10, 2022
• Study Start: December 4, 2023
• Primary Completion: June 3, 2025
• Study Completion: June 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)