NCT03400059

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 6, 2025

Completed
Last Updated

January 6, 2025

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

January 9, 2018

Results QC Date

February 18, 2024

Last Update Submit

November 14, 2024

Conditions

Chronic Migraine

Keywords

Prophylaxis, Headache, Preventative Treatment

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.

    Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.

    Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Secondary Outcomes (17)

  • Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period

    Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

  • Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days

    Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

  • Mean Change From Baseline to Follow-up Period in Monthly Migraine Days

    Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

  • Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities

    Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

  • Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities

    Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

  • +12 more secondary outcomes

Study Arms (2)

Active Treatment

EXPERIMENTAL
Device: Chordate System S211 in treatment mode

Sham Treatment

SHAM COMPARATOR
Device: Chordate System S211 in placebo mode

Interventions

Chordate System S211 in treatment modeDEVICE

Chordate System S211 in treatment mode

Active Treatment
Chordate System S211 in placebo modeDEVICE

Chordate System S211 in placebo mode

Sham Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 (ICF);
  • Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;
  • Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month for more than 3 months before screening including at least 8 migraine days) according to the IHS classification (International Classification of Headache Disorders \[ICHD\]-III beta);
  • Migraine onset before the age of 60 years;
  • Reported history of migraine for at least 1 year before screening;
  • Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
  • Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of 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.

You may not qualify if:

  • Unable to distinguish between migraine headaches and other headache types;
  • Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
  • Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
  • Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
  • History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;
  • Fitted with a pacemaker/defibrillator;
  • Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
  • Ongoing upper respiratory infection or malignancy in the nasal cavity;
  • History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
  • Head injury or open wound that contraindicates use of the Chordate Headband;
  • Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;
  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Terveystalo Ruoholahti

Helsinki, 00180, Finland

Location

Helsingin päänsärkykeskus / Aava Itäkeskus

Helsinki, 00930, Finland

Location

Terveystalo Tampere

Tampere, 33100, Finland

Location

Suomen Terveystalo Turku

Turku, 20100, Finland

Location

Lewis Neurologie

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

Neurologie- & Kopfschmerzzentrum

München, Bavaria, 80802, Germany

Location

Klinikum Großhadern / Neurologische Klinik der Universität München

München, Bavaria, 81377, Germany

Location

Migräne-Klinik Königstein

Königstein im Taunus, Hesse, 61462, Germany

Location

Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie

Rostock, Mecklenburg-Vorpommern, 18147, Germany

Location

CTC North am Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (1)

  • Hoffmann J, Kaube H, Rimmele F, Jurgens TP, Nissila M, Gaul C, Kallela M, Keski-Santti P, Sumelahti ML, Straube A, Lewis D, Hoffmann V, Wirtz L, Rempel A, Bohm O, May A. Kinetic Oscillation Stimulation for the Preventive Treatment of Chronic Migraine: A Randomized, Double-Blind, Sham-Controlled Trial. Neurology. 2025 Feb 11;104(3):e210220. doi: 10.1212/WNL.0000000000210220. Epub 2025 Jan 9.

    PMID: 39787477DERIVED

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Jan Hermansson
Organization
Chordate Medical AB
jan.hermansson@chordate.com
+46 8 400 115 86

Study Officials

  • Arne May, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

March 22, 2018

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

January 6, 2025

Results First Posted

January 6, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" 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 deidentified 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.

Locations

FI(4)DE(6)