PM009 - Study in Chronic Migraine using the Chordate System S220

• Research type

  Research Study

• Full title

  An open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation in the preventive treatment of chronic migraine on patients not responding to a preventive treatment with monoclonal antibodies targeting the CGRP pathway.

• IRAS ID

  311516

• Contact name

  Jan Hermansson

• Contact email

  jan.hermansson@chordate.com

• Sponsor organisation

  Chordate Medical AB

• Clinicaltrials.gov Identifier

  NCT05273151

• Clinicaltrials.gov Identifier

  n/a, n/a

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  This is an open pilot study, non-controlled, single centre investigation.
  The study consists of a 4-week screening period, a 6-week treatment period, and a 12-week follow-up period.
  Participants who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the participants will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as baseline for the performance assessments.
  Participants who completed the screening period and continue to meet the eligibility criteria after review of diary entries by the investigator will receive treatment. The participants will receive 6 treatments with the Chordate System S220 at weekly intervals at the site (Day 0 to 35; treatment Visit [V] 1 to 6) and continue to maintain a daily diary. After completion of the 6-week study treatment period (V1 to V6), participants will be treated monthly and followed up for another 12 weeks. The final visit will be performed on Day 125, 12 weeks after the last study treatment. During the 12-week follow-up, the participants will continue to complete a daily diary. 30 participants will be screened and it is estimated that 25 of these will be included and treated. It is estimated that participants will be in the study for approximately 22 weeks.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  22/NE/0076

• Date of REC Opinion

  11 Jul 2022

• REC opinion

  Further Information Favourable Opinion