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

Primary Purpose

Chronic Migraine

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Chordate System S211 in treatment mode

Chordate System S211 in placebo mode

About this trial

This is an interventional prevention trial for Chronic Migraine focused on measuring Prophylaxis, Headache, Preventative Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (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.

Exclusion Criteria:

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;
Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.

Sites / Locations

Terveystalo Ruoholahti
Helsingin päänsärkykeskus / Aava Itäkeskus
Terveystalo Tampere
Suomen Terveystalo Turku
Lewis Neurologie
Neurologie- & Kopfschmerzzentrum
Klinikum Großhadern / Neurologische Klinik der Universität München
Migräne-Klinik Königstein
Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie
CTC North am Universitätsklinikum Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Treatment

Sham Treatment

Arm Description

Outcomes

Primary Outcome Measures

Mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period (V3 to V7).

Secondary Outcome Measures

Mean change from Baseline in monthly headache days with moderate to severe intensity in follow-up period

Mean change from Baseline in monthly migraine days

Proportion of subjects with 30% or greater reduction in headache days of moderate to severe intensity

Proportion of subjects with 50% or greater reduction of headache days of moderate to severe intensity

Change in the use of abortive medication

Headache impact test

Migraine disability assessment

Migraine-Specific Quality of Life Questionnaire (MSQ)

Patient global impression of severity

Incidence of adverse events

Full Information

NCT ID

NCT03400059

First Posted

January 9, 2018

Last Updated

September 6, 2022

Sponsor

Chordate Medical

Collaborators

Vinnova (Swedish Governmental Agency for Innovation Systems), FGK Clinical Research GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03400059

Brief Title

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

Official Title

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 22, 2018 (Actual)

Primary Completion Date

August 1, 2022 (Actual)

Study Completion Date

August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chordate Medical

Collaborators

Vinnova (Swedish Governmental Agency for Innovation Systems), FGK Clinical Research GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of a medical device. The study consists of a 4-week screening period, a 6-week treatment period (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week follow-up period. The study primarily aims at evaluating the effect of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment on monthly headache days with moderate to severe intensity.

6. Conditions and Keywords

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

Chronic Migraine

Keywords

Prophylaxis, Headache, Preventative Treatment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment

Arm Type

Experimental

Arm Title

Sham Treatment

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Chordate System S211 in treatment mode

Intervention Description

Chordate System S211 in treatment mode

Intervention Type

Device

Intervention Name(s)

Chordate System S211 in placebo mode

Intervention Description

Chordate System S211 in placebo mode

Primary Outcome Measure Information:

Title

Mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period (V3 to V7).

Time Frame