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

Chronic Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400059
• Other study ID #: PM007
• Status: Completed
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Chordate Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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);

2. Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;

3. 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);

4. Migraine onset before the age of 60 years;

5. Reported history of migraine for at least 1 year before screening;

6. Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;

7. Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;

8. 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:

1. Unable to distinguish between migraine headaches and other headache types;

2. Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;

3. Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;

4. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;

5. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;

6. Fitted with a pacemaker/defibrillator;

7. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);

8. Ongoing upper respiratory infection or malignancy in the nasal cavity;

9. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;

10. Head injury or open wound that contraindicates use of the Chordate Headband;

11. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;

12. 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;

13. Pregnant and lactating women;

14. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;

15. Previous participation in this study;

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Device:
• Chordate System S211 in treatment mode
Chordate System S211 in treatment mode
• Chordate System S211 in placebo mode
Chordate System S211 in placebo mode

Locations

Country	Name	City	State
Finland	Helsingin päänsärkykeskus / Aava Itäkeskus	Helsinki
Finland	Terveystalo Ruoholahti	Helsinki
Finland	Terveystalo Tampere	Tampere
Finland	Suomen Terveystalo Turku	Turku
Germany	CTC North am Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Migräne-Klinik Königstein	Königstein Im Taunus	Hessen
Germany	Klinikum Großhadern / Neurologische Klinik der Universität München	München	Bayern
Germany	Neurologie- & Kopfschmerzzentrum	München	Bayern
Germany	Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie	Rostock	Mecklenburg-Vorpommern
Germany	Lewis Neurologie	Stuttgart	Baden-Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
Chordate Medical	FGK Clinical Research GmbH, Vinnova (Swedish Governmental Agency for Innovation Systems)

Countries where clinical trial is conducted

Finland,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Secondary	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 14 to Day 42
Secondary	Mean change from Baseline in monthly migraine days		Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Secondary	Proportion of subjects with 30% or greater reduction in headache days of moderate to severe intensity		Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Secondary	Proportion of subjects with 50% or greater reduction of headache days of moderate to severe intensity		Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Secondary	Change in the use of abortive medication		Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Secondary	Headache impact test		Days -28, 0, 14, 42, 70
Secondary	Migraine disability assessment		Days -28, 0, 14, 42, 70
Secondary	Migraine-Specific Quality of Life Questionnaire (MSQ)		Days -28, 0, 14, 42, 70
Secondary	Patient global impression of severity		Days -28, 0, 14, 42, 70
Secondary	Incidence of adverse events		Days 0, 7, 14, 21, 28, 35, 42, 70