Clinical trial NCT02243865: Chordate System Prophylactic Migraine Clinical Investigation
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
First posted: 2014-09-18
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
timeFrame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Secondary outcomes:
measure: Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
timeFrame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
measure: Responder Rate
timeFrame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
measure: Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
timeFrame: From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)
measure: Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
timeFrame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
measure: Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
timeFrame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
measure: Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
timeFrame: At visit 4 day 98, ± 7 days
measure: Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
timeFrame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
measure: Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
timeFrame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Stortorgets neurologmottagning
city: Linköping
country: Sweden
facility: Läkarcentrum Stångåblick
city: Stockholm
country: Sweden
facility: Neurolgy Clinic
city: Vällingby
country: Sweden
facility: Neurologmottagningen Vällingby sjukhus
Study officials:
affiliation: Linkoeping University
name: Jan-Åke Åkesson, MD
role: STUDY_CHAIR
References: