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

Primary Purpose

Chronic Migraine

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
KOS (Intranasal kinetic oscillation stimulation)
Sponsored by
Chordate Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION AND EXCLUSION CRITERIA: Inclusion Criteria 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. Exclusion Criteria 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. 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. Only at baseline visit (day 0) If subject missed >4 days of eDiary entry, subject will be withdrawn.

Sites / Locations

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum
  • Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz
  • Kopfschmerzzentrum Frankfurt
  • Klinikum St. Georg Klinik für Neurologie
  • Universitätsklinikum Tübingen Klinik für Neurologie
  • Shaare Zedek Medical Center, Neurology Clinics,Recruiting
  • Università de L'Aquila Dipartimento di Scienze Cliniche applicate e Biotecnologie SSD Neurologia
  • IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee
  • Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation
  • Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia
  • IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore
  • Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University HospitalRecruiting
  • Hull Royal Infirmary, Hull University Teaching Hospital NHS TrustRecruiting
  • National Migraine Centre
  • St. George's University Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

KOS treatment

Arm Description

Treatment with intranasal kinetic oscillation stimulation (KOS)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.
Migraine days is collected in an eDiary.
To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.
All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with KOS
Number of patients who are responders
Responders are classified as responder (less migraine/headache days) or non-responder (same or worsening of migraine/headache days). A responder is a patient who has decrease of headache/migraine days whilst a non responder had no or the same number of headache/migraine days
Number of patients who decrease use of abortive medication
Intake of abortive medications are registered in eDiary and will be calculated on patient level
Mean change in Headache Impact Test (HIT-6)
HIT-6 consist of 6 questions HIT-6 with scores from 6 to 13 where 13 is worst case per question so lower score is better outcome than high scores.
Mean change in Subject global severity
Patient Global severity is a scale with four (4) scores, where normal (0) is the lowest and show no problems whilst severe (3) is the worst score 0. Normal Mild Moderate Severe

Full Information

First Posted
April 25, 2023
Last Updated
October 17, 2023
Sponsor
Chordate Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05843721
Brief Title
Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
Official Title
An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chordate Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An non controlled, long term, multi center investigation
Detailed Description
Subjects who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the subjects will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as Baseline for the performance assessments. A non-controlled, long term, multi-center investigation for symptom improvement in subjects suffering headache and migraine attacks. During the run-in (baseline) period and through the whole study the subjects will continue using their existing prescribed or over the counter (OTC) treatments. Following the run-in period (4 weeks) the subjects will be treated six times within a period that is approximately 6 weeks. The first treatment will be given the first day after the run-in period. During 12-month follow-up period (from the time of the first treatment), subjects will be treated when needed but a maximum of 14 treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KOS treatment
Arm Type
Other
Arm Description
Treatment with intranasal kinetic oscillation stimulation (KOS)
Intervention Type
Device
Intervention Name(s)
KOS (Intranasal kinetic oscillation stimulation)
Intervention Description
Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.
Primary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.
Description
Migraine days is collected in an eDiary.
Time Frame
Baseline to 12 month
Title
To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.
Description
All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with KOS
Time Frame
Baseline to 12 month
Title
Number of patients who are responders
Description
Responders are classified as responder (less migraine/headache days) or non-responder (same or worsening of migraine/headache days). A responder is a patient who has decrease of headache/migraine days whilst a non responder had no or the same number of headache/migraine days
Time Frame
Baseline to 12 month
Title
Number of patients who decrease use of abortive medication
Description
Intake of abortive medications are registered in eDiary and will be calculated on patient level
Time Frame
Baseline to 12 month
Title
Mean change in Headache Impact Test (HIT-6)
Description
HIT-6 consist of 6 questions HIT-6 with scores from 6 to 13 where 13 is worst case per question so lower score is better outcome than high scores.
Time Frame
Baseline to 12 month
Title
Mean change in Subject global severity
Description
Patient Global severity is a scale with four (4) scores, where normal (0) is the lowest and show no problems whilst severe (3) is the worst score 0. Normal Mild Moderate Severe
Time Frame
Baseline to 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION AND EXCLUSION CRITERIA: Inclusion Criteria 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. Exclusion Criteria 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. 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. Only at baseline visit (day 0) If subject missed >4 days of eDiary entry, subject will be withdrawn.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Hoffmann, MD, PhD
Phone
+44-20-3299 3106
Email
jan.hoffmann@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Tassorelli, Prof,MD,PhD
Phone
+39 0382 380207
Email
cristina.tassorelli@mondino.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hoffmann, MD, PhD
Organizational Affiliation
Wellcome Foundation Building, Denmark Hill Campus King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gudrun Gossray, PD, MD
Phone
+49 (0) 351 458-2063
Email
gudrun.gossrau2@uniklinikum-dresden.de
Facility Name
Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz
City
Essen
ZIP/Postal Code
D-45147
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagny Holle-Lee, Prof MD
Phone
+49 (0) 201 / 723-84852
Email
dagny.holle-lee@uk-essen.de
Facility Name
Kopfschmerzzentrum Frankfurt
City
Frankfurt am main
ZIP/Postal Code
D-65929
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charly Gaul, MD
Phone
+49 (0) 69 204 368 60
Email
c.gaul@kopfschmerz-frankfurt.de
Facility Name
Klinikum St. Georg Klinik für Neurologie
City
Leipzig
ZIP/Postal Code
D-04129
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torsten Kraya, PD, MD
Phone
49 (0) 341 909-3701
Email
Torsten.Kraya@sanktgeorg.de
Facility Name
Universitätsklinikum Tübingen Klinik für Neurologie
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigrid Schuh-Hofer, Prof, MD
Phone
+49 (0) 7071 29-80442
Email
Sigrid.schuh-hofer@med.uni-tuebingen.de
Facility Name
Shaare Zedek Medical Center, Neurology Clinics,
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abraham Abrahama@szmc.org.il, MD
Phone
+972 545683879
Email
Abrahama@szmc.org.il
Facility Name
Università de L'Aquila Dipartimento di Scienze Cliniche applicate e Biotecnologie SSD Neurologia
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Sacco, Prof MD
Phone
+39 0862 433561
Email
simona.sacco@univaq.it
Facility Name
IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee
City
Milano
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Doretti, MD
Phone
+39 02 619112937
Email
a.doretti@auxologico.it
Facility Name
Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Tassorelli, Prof, MD,PhD
Phone
+39 0382 380207
Email
cristina.tassorelli@mondino.it
Facility Name
Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vernieri Fabrizio, Prof MD
Phone
+39 06 225411220
Email
f.vernieri@policlinicocampus.it
Facility Name
IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore
City
Roma
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piero Barbanti, Prof, MD
Phone
+39335 707 1457
Email
piero.barbanti@sanraffaele.it
Facility Name
Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alok Tyagi, Prof MD
Phone
+44 07765 554172
Email
Alok.Tyagi@ggc.scot.nhs.uk
Facility Name
Hull Royal Infirmary, Hull University Teaching Hospital NHS Trust
City
Hull
ZIP/Postal Code
HU3 2J
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayyaz Ahmed, Prof MD
Phone
+44 07973 144051
Email
fayyaz.ahmed@nhs.net
Facility Name
National Migraine Centre
City
London
ZIP/Postal Code
NW11 7HB
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
St. George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Logan, Physiothe.
Phone
+44 02087 254163
Email
Anne-Marie.Logan@stgeorges.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to uncertainties in EU data protection legislation individual de-identified participant data are not shared. The main uncertainty is the concept of what "de-identified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as de-identified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.

Learn more about this trial

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

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