Trial Outcomes & Findings for Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine (NCT NCT03400059)

Last Updated: 2025-01-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Results posted on

2025-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Active Treatment Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Overall Study STARTED	75	69
Overall Study Randomization	75	69
Overall Study Safety Analysis Set (SAF)	76	68
Overall Study Full Analysis Set (FAS)	71	69
Overall Study COMPLETED	67	65
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=76 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=68 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	67 Participants n=7 Participants	143 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	48 years n=5 Participants	46 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	57 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized White	75 Participants n=5 Participants	68 Participants n=7 Participants	143 Participants n=5 Participants
Race/Ethnicity, Customized Arabian (Jordan)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Finland	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants
Region of Enrollment Germany	51 participants n=5 Participants	46 participants n=7 Participants	97 participants n=5 Participants
BMI	26.3 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants	25.3 kg/m^2 STANDARD_DEVIATION 5.0 • n=7 Participants	25.9 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Population: FAS

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=67 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo 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.	-3.45 change in days Standard Error 0.62	-1.22 change in days Standard Error 0.62

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=66 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period	-3.15 change in days Standard Error 0.59	-0.47 change in days Standard Error 0.59

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=67 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days	-3.57 change in days Standard Error 0.60	-1.17 change in days Standard Error 0.60

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=66 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Mean Change From Baseline to Follow-up Period in Monthly Migraine Days	-3.72 change in days Standard Error 0.60	-0.85 change in days Standard Error 0.60

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=67 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities	-2.88 change in days Standard Error 0.57	-1.35 change in days Standard Error 0.58

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=66 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities	-3.65 change in days Standard Error 0.62	-1.75 change in days Standard Error 0.62

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=68 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=67 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period	32 Participants	17 Participants

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=69 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=67 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period	27 Participants	19 Participants

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=68 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=67 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period	20 Participants	11 Participants

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=69 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=67 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period	16 Participants	9 Participants

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=67 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Change in the Use of Abortive Medication in Performance Assessment Period	-2.016 change in days Standard Deviation 4.565	-0.857 change in days Standard Deviation 4.721

SECONDARY outcome

Timeframe: Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70

Population: FAS

Outcome measures

Outcome measures
Measure	Active Treatment n=66 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=65 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Change in the Use of Abortive Medication in Follow-up Period	-2.490 change in days Standard Deviation 4.260	-0.660 change in days Standard Deviation 5.552

SECONDARY outcome

Timeframe: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

Population: assessments of individual subjects missing at some visits

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=71 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=69 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Headache Impact Test Visit 3	-2.6 change in score on a scale from Baseline Standard Deviation 5.2	-1.5 change in score on a scale from Baseline Standard Deviation 3.1
Headache Impact Test Visit 7	-4.1 change in score on a scale from Baseline Standard Deviation 6.8	-2.2 change in score on a scale from Baseline Standard Deviation 4.8
Headache Impact Test Follow-up visit	-3.8 change in score on a scale from Baseline Standard Deviation 7.4	-1.7 change in score on a scale from Baseline Standard Deviation 5.4

SECONDARY outcome

Timeframe: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

Population: assessments of individual subjects missing at some visits

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=71 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=69 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive Visit 3	7.4 change in score on a scale from Baseline Standard Deviation 16.3	5.4 change in score on a scale from Baseline Standard Deviation 11.2
Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive Visit 7	13.3 change in score on a scale from Baseline Standard Deviation 19.9	7.5 change in score on a scale from Baseline Standard Deviation 17.0
Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive Follow-up	11.9 change in score on a scale from Baseline Standard Deviation 21.4	4.9 change in score on a scale from Baseline Standard Deviation 19.8

SECONDARY outcome

Timeframe: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

Population: assessments of individual subjects missing at some visits

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=71 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=69 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
MSQ - Role Function - Preventive Visit 3	4.2 change in score on a scale from Baseline Standard Deviation 17.4	0.7 change in score on a scale from Baseline Standard Deviation 10.9
MSQ - Role Function - Preventive Visit 7	9.2 change in score on a scale from Baseline Standard Deviation 20.8	4.8 change in score on a scale from Baseline Standard Deviation 16.6
MSQ - Role Function - Preventive Follow-up	9.8 change in score on a scale from Baseline Standard Deviation 22.2	-0.7 change in score on a scale from Baseline Standard Deviation 19.8

SECONDARY outcome

Timeframe: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)

Population: assessments of individual subjects missing at some visits

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=71 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=69 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
MSQ - Emotional Function Visit 7	10.2 change in score on a scale from Baseline Standard Deviation 23.5	5.8 change in score on a scale from Baseline Standard Deviation 19.2
MSQ - Emotional Function Follow-up	11.5 change in score on a scale from Baseline Standard Deviation 25.2	2.5 change in score on a scale from Baseline Standard Deviation 24.7
MSQ - Emotional Function Visit 3	7.0 change in score on a scale from Baseline Standard Deviation 16.2	3.0 change in score on a scale from Baseline Standard Deviation 14.2

SECONDARY outcome

Timeframe: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)

Population: assessments of individual subjects missing at some visits

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

Outcome measures

Outcome measures
Measure	Active Treatment n=71 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=69 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Patient Global Impression of Severity (PGI-S) Visit 7 · Not done	1 Participants	1 Participants
Patient Global Impression of Severity (PGI-S) Visit 7 · normal	23 Participants	25 Participants
Patient Global Impression of Severity (PGI-S) Visit 7 · mild	17 Participants	10 Participants
Patient Global Impression of Severity (PGI-S) Visit 7 · moderate	21 Participants	18 Participants
Patient Global Impression of Severity (PGI-S) Visit 7 · severe	6 Participants	13 Participants
Patient Global Impression of Severity (PGI-S) Follow-up · Not done	0 Participants	0 Participants
Patient Global Impression of Severity (PGI-S) Follow-up · normal	22 Participants	23 Participants
Patient Global Impression of Severity (PGI-S) Follow-up · mild	17 Participants	9 Participants
Patient Global Impression of Severity (PGI-S) Follow-up · moderate	20 Participants	18 Participants
Patient Global Impression of Severity (PGI-S) Follow-up · severe	10 Participants	17 Participants
Patient Global Impression of Severity (PGI-S) Screening · Not done	1 Participants	0 Participants
Patient Global Impression of Severity (PGI-S) Screening · normal	13 Participants	13 Participants
Patient Global Impression of Severity (PGI-S) Screening · mild	7 Participants	4 Participants
Patient Global Impression of Severity (PGI-S) Screening · moderate	25 Participants	24 Participants
Patient Global Impression of Severity (PGI-S) Screening · severe	25 Participants	28 Participants
Patient Global Impression of Severity (PGI-S) Visit 1 · Not done	2 Participants	1 Participants
Patient Global Impression of Severity (PGI-S) Visit 1 · normal	21 Participants	20 Participants
Patient Global Impression of Severity (PGI-S) Visit 1 · mild	5 Participants	6 Participants
Patient Global Impression of Severity (PGI-S) Visit 1 · moderate	22 Participants	19 Participants
Patient Global Impression of Severity (PGI-S) Visit 1 · severe	21 Participants	23 Participants
Patient Global Impression of Severity (PGI-S) Visit 3 · Not done	1 Participants	1 Participants
Patient Global Impression of Severity (PGI-S) Visit 3 · normal	22 Participants	24 Participants
Patient Global Impression of Severity (PGI-S) Visit 3 · mild	13 Participants	9 Participants
Patient Global Impression of Severity (PGI-S) Visit 3 · moderate	21 Participants	20 Participants
Patient Global Impression of Severity (PGI-S) Visit 3 · severe	12 Participants	14 Participants

SECONDARY outcome

Timeframe: Days 0, 7, 14, 21, 28, 35, 42, 70

Population: SAF

n (%) of patients

Outcome measures

Outcome measures
Measure	Active Treatment n=76 Participants Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=68 Participants Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Incidence of Adverse Events (AEs) Any treatment emergent adverse event related to procedure	17 Participants	13 Participants
Incidence of Adverse Events (AEs) Any adverse event	49 Participants	41 Participants
Incidence of Adverse Events (AEs) Any treatment emergent adverse event	48 Participants	41 Participants
Incidence of Adverse Events (AEs) any serious treatment emergent adverse event	1 Participants	0 Participants
Incidence of Adverse Events (AEs) Any treatment emergent adverse event related to medical device	2 Participants	5 Participants

Adverse Events

Active Treatment

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Treatment n=76 participants at risk Chordate System S211 in treatment mode: Chordate System S211 in treatment mode	Sham Treatment n=68 participants at risk Chordate System S211 in placebo mode: Chordate System S211 in placebo mode
Injury, poisoning and procedural complications foot fracture	1.3% 1/76 • Number of events 1 • 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 \[shortened\] The definition of AE in this study does not include adverse experiences observed by the patient or in the patient before the investigational medical device application. It does not include anticipated device effects of mild character. It does also not include migraine-associated symptoms. All AEs were assessed in terms of seriousness (yes, no), severity, outcome, relationship to the investigational medical device, and relationship to study procedures.	0.00% 0/68 • 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 \[shortened\] The definition of AE in this study does not include adverse experiences observed by the patient or in the patient before the investigational medical device application. It does not include anticipated device effects of mild character. It does also not include migraine-associated symptoms. All AEs were assessed in terms of seriousness (yes, no), severity, outcome, relationship to the investigational medical device, and relationship to study procedures.

Other adverse events

Additional Information

Dr Jan Hermansson

Chordate Medical AB

Phone: +46 8 400 115 86

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place