An interventional study of Chordate System S211 in treatment mode and Chordate System S211 in placebo mode in Chronic Migraine, sponsored by Chordate Medical. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Chordate Medical · Not applicable, Interventional, and Prevention
Among 33 studies in Headache with a site in Germany — 1 open to participants now, 4 under way, 2 of them phase 3. Headache · Germany.
Among the 33 studies in Headache with a site in Germany, this one is the 25th largest by enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2018, is one of 5 with no phase, and was the 18th registered.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
Browse Headache studies →1 of the 33 studies in Headache with a site in Germany is open now. Recruiting first, the newest first:
Hospital Universitari Vall d'Hebron Research Institute · Sites in Germany, United States, Argentina and 10 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 83 Headache studies recruiting now, 30 (36%) set no upper age limit and 44 (53%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 144 is above the median of 65 across 560 interventional studies indexed under Headache.
Median enrollment 456 across the 28 interventional studies, 140 across the 5 observational. Of the 27 that completed or were terminated, 17 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 33 have an industry lead sponsor. The 10 most frequent:
Chordate Medical is the lead sponsor of 9 studies on the registry; none are open to participants now.
Chordate Medical has 1 study filed under Headache — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 33 studies in Headache with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Chordate System S211 in treatment mode
Device: Chordate System S211 in placebo mode
Chordate System S211 in treatment mode
Chordate System S211 in placebo mode
Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.
Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
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 43 to Day 70
Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Mean Change From Baseline to Follow-up Period in Monthly Migraine Days
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Change in the Use of Abortive Medication in Performance Assessment Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42
Change in the Use of Abortive Medication in Follow-up Period
Time frame: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70
Headache Impact Test
The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact. Reported is the change from Baseline in the final total score at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive
The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
MSQ - Role Function - Preventive
The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
MSQ - Emotional Function
The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit.
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Patient Global Impression of Severity (PGI-S)
The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe
Time frame: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)
Incidence of Adverse Events (AEs)
n (%) of patients
Time frame: Days 0, 7, 14, 21, 28, 35, 42, 70
| Milestone | Active Treatment | Sham Treatment |
|---|---|---|
| Started | 75 | 69 |
| Randomization | 75 | 69 |
| Safety analysis set (saf) | 76 | 68 |
| Full analysis set (fas) | 71 | 69 |
| Completed | 67 | 65 |
| Not completed | 8 | 4 |
Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period. | -3.45 ± 0.62 | -1.22 ± 0.62 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period | -3.15 ± 0.59 | -0.47 ± 0.59 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days | -3.57 ± 0.60 | -1.17 ± 0.60 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Mean Change From Baseline to Follow-up Period in Monthly Migraine Days | -3.72 ± 0.60 | -0.85 ± 0.60 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | -2.88 ± 0.57 | -1.35 ± 0.58 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities | -3.65 ± 0.62 | -1.75 ± 0.62 |
| Participants | Active Treatment | Sham Treatment |
|---|---|---|
| Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period | 32 | 17 |
| Participants | Active Treatment | Sham Treatment |
|---|---|---|
| Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period | 27 | 19 |
| Participants | Active Treatment | Sham Treatment |
|---|---|---|
| Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period | 20 | 11 |
| Participants | Active Treatment | Sham Treatment |
|---|---|---|
| Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period | 16 | 9 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Change in the Use of Abortive Medication in Performance Assessment Period | -2.016 ± 4.565 | -0.857 ± 4.721 |
| change in days | Active Treatment | Sham Treatment |
|---|---|---|
| Change in the Use of Abortive Medication in Follow-up Period | -2.490 ± 4.260 | -0.660 ± 5.552 |
The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact. Reported is the change from Baseline in the final total score at the respective visit.
| change in score on a scale from Baseline | Active Treatment | Sham Treatment |
|---|---|---|
| Visit 3 | -2.6 ± 5.2 | -1.5 ± 3.1 |
| Visit 7 | -4.1 ± 6.8 | -2.2 ± 4.8 |
| Follow-up visit | -3.8 ± 7.4 | -1.7 ± 5.4 |
The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit.
| change in score on a scale from Baseline | Active Treatment | Sham Treatment |
|---|---|---|
| Visit 3 | 7.4 ± 16.3 | 5.4 ± 11.2 |
| Visit 7 | 13.3 ± 19.9 | 7.5 ± 17.0 |
| Follow-up | 11.9 ± 21.4 | 4.9 ± 19.8 |
The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit.
| change in score on a scale from Baseline | Active Treatment | Sham Treatment |
|---|---|---|
| Visit 3 | 4.2 ± 17.4 | 0.7 ± 10.9 |
| Visit 7 | 9.2 ± 20.8 | 4.8 ± 16.6 |
| Follow-up | 9.8 ± 22.2 | -0.7 ± 19.8 |
The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status. Reported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit.
| change in score on a scale from Baseline | Active Treatment | Sham Treatment |
|---|---|---|
| Visit 3 | 7.0 ± 16.2 | 3.0 ± 14.2 |
| Visit 7 | 10.2 ± 23.5 | 5.8 ± 19.2 |
| Follow-up | 11.5 ± 25.2 | 2.5 ± 24.7 |
The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe
| Participants | Active Treatment | Sham Treatment |
|---|---|---|
| Screening — Not done | 1 | 0 |
| Screening — normal | 13 | 13 |
| Screening — mild | 7 | 4 |
| Screening — moderate | 25 | 24 |
| Screening — severe | 25 | 28 |
| Visit 1 — Not done | 2 | 1 |
| Visit 1 — normal | 21 | 20 |
| Visit 1 — mild | 5 | 6 |
| Visit 1 — moderate | 22 | 19 |
| Visit 1 — severe | 21 | 23 |
| Visit 3 — Not done | 1 | 1 |
| Visit 3 — normal | 22 | 24 |
| Visit 3 — mild | 13 | 9 |
| Visit 3 — moderate | 21 | 20 |
| Visit 3 — severe | 12 | 14 |
| Visit 7 — Not done | 1 | 1 |
| Visit 7 — normal | 23 | 25 |
| Visit 7 — mild | 17 | 10 |
| Visit 7 — moderate | 21 | 18 |
| Visit 7 — severe | 6 | 13 |
| Follow-up — Not done | 0 | 0 |
| Follow-up — normal | 22 | 23 |
| Follow-up — mild | 17 | 9 |
| Follow-up — moderate | 20 | 18 |
| Follow-up — severe | 10 | 17 |
n (%) of patients
| Participants | Active Treatment | Sham Treatment |
|---|---|---|
| Any adverse event | 49 | 41 |
| Any treatment emergent adverse event | 48 | 41 |
| any serious treatment emergent adverse event | 1 | 0 |
| Any treatment emergent adverse event related to medical device | 2 | 5 |
| Any treatment emergent adverse event related to procedure | 17 | 13 |
Collected over From Day 0 (during and after the first treatment with the investigational medicinal device) to Day 70 (final follow-up visit), i.e, about 10 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Treatment | 0/76 (0%) | 1/76 (1.3%) | 49/76 (64.5%) |
| Sham Treatment | 0/68 (0%) | 0/68 (0%) | 41/68 (60.3%) |
| Event | Active Treatment | Sham Treatment |
|---|---|---|
| foot fractureInjury, poisoning and procedural complications | 1/76 | — |
| Event | Active Treatment | Sham Treatment |
|---|---|---|
| DizzinessNervous system disorders | 7/76 | 2/68 |
| NasopharyngitisInfections and infestations | 6/76 | 6/68 |
| EpixtaxisRespiratory, thoracic and mediastinal disorders | 5/76 | 4/68 |
| Corona Virus infectionInfections and infestations | 4/76 | 4/68 |
| Upper respiratory tract infectionInfections and infestations | 1/76 | 4/68 |
| Neck painMusculoskeletal and connective tissue disorders | 4/76 | 3/68 |
| RhinorrheaRespiratory, thoracic and mediastinal disorders | 4/76 | 3/68 |
| VomitingGastrointestinal disorders | 3/76 | 0/68 |
| VertigoEar and labyrinth disorders | 0/76 | 2/68 |
| Lacrimation increasedEye disorders | 1/76 | 2/68 |
One subject was randomized to and treated with placebo and was assigned to the placebo group in the FAS, but received active treatment for a short time at Visit 1 and was therefore assigned to the active group in the SAF. Baseline subject demographics are based on the SAF.
| Age, Categorical(Participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 76 | 67 | 143 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Median | 48 (20 to 64) | 46 (19 to 67) | 48 (19 to 67) |
| Sex: Female, Male(Participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Female | 65 | 57 | 122 |
| Male | 11 | 11 | 22 |
| Race/Ethnicity, Customized(Participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| White | 75 | 68 | 143 |
| Arabian (Jordan) | 1 | 0 | 1 |
| Region of Enrollment(participants) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Finland | 25 | 22 | 47 |
| Germany | 51 | 46 | 97 |
| BMI(kg/m^2) | Active Treatment | Sham Treatment | Total |
|---|---|---|---|
| Mean | 26.3 ± 5.6 | 25.3 ± 5.0 | 25.9 ± 5.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.
Ran from Mar 2018 to primary completion in Aug 2022, 52 months.
Results were first posted in Jan 2025, 2 years 5 months after primary completion.
Of 193 interventional studies with no phase under Headache, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 52 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Chordate Medical