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

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ClinicalTrials.gov Identifier: NCT03400059
Recruitment Status : Not yet recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Vinnova (Swedish Governmental Agency for Innovation Systems)
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Chordate Medical

Brief 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.

Condition or disease Intervention/treatment
Chronic Migraine Device: Chordate System S211 in treatment mode Device: Chordate System S211 in placebo mode

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active Treatment Device: Chordate System S211 in treatment mode
Chordate System S211 in treatment mode
Sham Comparator: Sham Treatment Device: Chordate System S211 in placebo mode
Chordate System S211 in placebo mode



Primary Outcome Measures :
  1. 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). [ Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 ]

Secondary Outcome Measures :
  1. Mean change from Baseline in monthly headache days with moderate to severe intensity in follow-up period [ Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 ]
  2. Mean change from Baseline in monthly migraine days [ Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 ]
  3. Proportion of subjects with 30% or greater reduction in headache days of moderate to severe intensity [ Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 ]
  4. Proportion of subjects with 50% or greater reduction of headache days of moderate to severe intensity [ Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 ]
  5. Change in the use of abortive medication [ Time Frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42 ]
  6. Headache impact test [ Time Frame: Days -28, 0, 14, 42, 70 ]
  7. Migraine disability assessment [ Time Frame: Days -28, 0, 14, 42, 70 ]
  8. Migraine-Specific Quality of Life Questionnaire (MSQ) [ Time Frame: Days -28, 0, 14, 42, 70 ]
  9. Patient global impression of severity [ Time Frame: Days -28, 0, 14, 42, 70 ]
  10. Incidence of adverse events [ Time Frame: Days 0, 7, 14, 21, 28, 35, 42, 70 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400059


Contacts
Contact: Stefan Heß, Dr. +49 (0)89 893119-0 info@fgk-cro.de

Locations
Germany
Neurologie- & Kopfschmerzzentrum Not yet recruiting
München, Bayern, Germany, 80802
Klinikum Großhadern / Neurologische Klinik der Universität München Not yet recruiting
München, Bayern, Germany, 81377
Migräne-Klinik Königstein Not yet recruiting
Königstein Im Taunus, Hessen, Germany, 61462
CTC North am Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20251
Sponsors and Collaborators
Chordate Medical
Vinnova (Swedish Governmental Agency for Innovation Systems)
FGK Clinical Research GmbH
Investigators
Principal Investigator: Jan Hoffmann, PD Dr. Universitätsklinikum Hamburg-Eppendorf

Responsible Party: Chordate Medical
ClinicalTrials.gov Identifier: NCT03400059     History of Changes
Other Study ID Numbers: PM007
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chordate Medical:
Prophylaxis, Headache, Preventative Treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases