Chordate System Prophylactic Migraine Clinical Investigation

NCT02243865 | Completed Results

• 1 other identifier: PM005
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration

  A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.

  From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)

Secondary Outcomes (8)

• 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

  From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)

• Responder Rate

  From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)

• Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration

  From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)

• 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

  From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)

• Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration

  From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)

Study Arms (2)

Chordate S200 + control module (CT100), active

EXPERIMENTAL

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

Device: Chordate System S200 + CT100 (active treatment)

Chordate S200 + control module (CT100), placebo

PLACEBO COMPARATOR

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

Device: Chordate System S200 + CT100 (placebo treatment)

Interventions

Chordate System S200 + CT100 (active treatment) 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), active

Chordate System S200 + CT100 (placebo treatment) 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.

Chordate S200 + control module (CT100), placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chordate Medical: lead

Study Sites (4)

Stortorgets neurologmottagning

Helsingborg, 25220, Sweden

Location

Läkarcentrum Stångåblick

Linköping, 582 19, Sweden

Location

Neurolgy Clinic

Stockholm, 11433, Sweden

Location

Neurologmottagningen Vällingby sjukhus

Vällingby, 162 68, Sweden

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr Jan-Åke Åkesson
• Organization: Chordate

info@chordate.com

+46 8 40015586

Study Officials

• Jan-Åke Åkesson, MD

  Linkoeping University

  STUDY CHAIR

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
• Masking Details: A placebo module, with one input and 6 outputs, was added to the Chordate S200 system. Some outputs delivered active treatment and others placebo. The operator received a coded envelope and according to that, either active treatment or placebo was selected. The operator did not know which outputs delivered treatment and which did not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 18, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)