Chordate System Prophylactic Migraine Clinical Investigation

NCT ID: NCT02243865

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine.

Detailed Description

This was a prospective, interventional, randomized, placebo-controlled, double-blind, multi-center clinical investigation of a medical device system.

A pilot study in which patients with frequent migraine attacks received intranasal KOS or placebo using the Chordate System S200 on two occasions.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Chordate S200 + control module (CT100), active

Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril

Group Type: EXPERIMENTAL

Chordate System S200 + CT100 (active treatment)

Intervention Type: DEVICE

Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).

Chordate S200 + control module (CT100), placebo

Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment

Group Type: PLACEBO_COMPARATOR

Chordate System S200 + CT100 (placebo treatment)

Intervention Type: DEVICE

Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.

Interventions

Chordate System S200 + CT100 (active treatment)

Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).

Intervention Type: DEVICE

Chordate System S200 + CT100 (placebo treatment)

Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.

Intervention Type: DEVICE

Eligibility 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 (ICF).
• Male or female aged between 18 and 65 years
• Diagnosed as suffering from migraine with or without aura according to International Headache Society´s (IHS) classification (International Classification of Headache Disorders (ICHD), 3rd edition, beta version)
• Reported history of 3 to 8 migraine episodes per month during previous 2 months, confirmed during baseline
• Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during baseline
• Onset of migraine headache occurred before age 50
• Reported history of migraine for more than one year
• Reported stable dose of prophylactic migraine medication(s), if any, during the two months prior to screening (visit 1), and willing and able to maintain stable dose(s) until the three months follow-up (visit 4)

Exclusion Criteria

• Meeting the ICHD criteria for medication overuse
• Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during baseline
• Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during baseline
• Unable to distinguish between migraine headaches and other headache types
• Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visits
• Ongoing treatment with implanted stimulator or other implanted device in the head and/or neck region
• Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds
• History of sinus surgery, transphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea
• Fitted with a pacemaker/defibrillator
• Previously treated with therapeutic radiation to the face (that could have influenced the nasal mucosa)
• Ongoing upper respiratory tract infection or a body temperature >38.5°C (at treatment), or malignancy in the nasal cavity
• History of regular nose bleeding (epistaxis), or concomitant condition that could cause excessive bleeding, including treatment with the anticoagulant Varan
• Head injury or open wound that contraindicates use of Chordate Headband
• Known allergy to polyvinylchloride, a material used in the 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
• Any change in migraine prophylaxis the previous two months
• Pregnant women
• Participation in a clinical research study within three months of enrolment or planned participation at any time during this clinical investigation
• Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members or any such individuals
• Headache or migraine episode within the 48 hours prior to the first treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chordate Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan-Åke Åkesson, MD

Role: STUDY_CHAIR

Linkoeping University

Locations

Stortorgets neurologmottagning

Helsingborg, , Sweden

Läkarcentrum Stångåblick

Linköping, , Sweden

Neurolgy Clinic

Stockholm, , Sweden

Neurologmottagningen Vällingby sjukhus

Vällingby, , Sweden

Countries

Sweden

Other Identifiers

PM005

Identifier Type: -

Identifier Source: org_study_id