Chronic MigraineNCT03400059

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

A study testing Chordate System S211 in treatment mode in people with Chronic Migraine, run by Chordate Medical at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Migraine
What is being tested?: Chordate System S211 in treatment mode
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 10 sitesin 2 countries
Study dates: 22 Mar 2018to 1 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 (inclusive) at the time of providing informed consent;
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);
Migraine onset before the age of 60 years;
Reported history of migraine for at least 1 year before screening;
Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;
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.

Who cannot join

Unable to distinguish between migraine headaches and other headache types;
Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;
Fitted with a pacemaker/defibrillator;

Show all 16Show fewer

Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
Ongoing upper respiratory infection or malignancy in the nasal cavity;
History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
Head injury or open wound that contraindicates use of the Chordate Headband;
Known allergy to polyvinylchloride, a material used in the Chordate 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;
Pregnant and lactating women;
Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
Previous participation in this study;
Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

Germany6 sites

CTC North am Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
Migräne-Klinik Königstein
Königstein im Taunus, Hesse, 61462
Neurologie- & Kopfschmerzzentrum
München, Bavaria, 80802
Klinikum Großhadern / Neurologische Klinik der Universität München
München, Bavaria, 81377
Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie
Rostock, Mecklenburg-Vorpommern, 18147
Lewis Neurologie
Stuttgart, Baden-Wurttemberg, 70178

Other trials in Germany

Finland4 sites

Terveystalo Ruoholahti
Helsinki, 00180
Helsingin päänsärkykeskus / Aava Itäkeskus
Helsinki, 00930
Terveystalo Tampere
Tampere, 33100
Suomen Terveystalo Turku
Turku, 20100

Other trials in Finland

About this study

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

Read the 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.

Conditions: Chronic Migraine
Being tested: Chordate System S211 in treatment mode, Chordate System S211 in placebo mode
Keywords: Prophylaxis, Headache, Preventative Treatment
Medical subject headings: Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chordate System S211 in treatment modeDevice
Chordate System S211 in treatment mode
Chordate System S211 in placebo modeDevice
Chordate System S211 in placebo mode

Study groups in NCT03400059
Study group	Role	What they receive
Active Treatment	Experimental	Not described Receives: Device: Chordate System S211 in treatment mode
Sham Treatment	Sham comparator	Not described Receives: Device: Chordate System S211 in placebo mode

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42

Secondary outcomes (17)

Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)
Incidence of Adverse Events (AEs)
n (%) of patients
Measured: Days 0, 7, 14, 21, 28, 35, 42, 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20181 Aug 2022

First posted17 Jan 2018
Study start22 Mar 2018
Primary completion1 Aug 2022
Study completion1 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03400059
Sponsor's protocol ID: PM007
Status last verified: Nov 2024
First submitted: 9 Jan 2018
Last updated: 6 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Hoffmann J, Kaube H, Rimmele F, Jurgens TP, Nissila M, Gaul C, Kallela M, Keski-Santti P, Sumelahti ML, Straube A, Lewis D, Hoffmann V, Wirtz L, Rempel A, Bohm O, May A. Kinetic Oscillation Stimulation for the Preventive Treatment of Chronic Migraine: A Randomized, Double-Blind, Sham-Controlled Trial. Neurology. 2025 Feb 11;104(3):e210220. doi: 10.1212/WNL.0000000000210220. Epub 2025 Jan 9.
PubMed 39787477

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03400059
Acronym / sponsor ID: PM007
Conditions: Chronic Migraine
Keywords: Prophylaxis, Headache, Preventative Treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Chordate MedicalIndustry (pharma, biotech, devices)
Collaborators: Vinnova, FGK Clinical Research GmbH
Study start: 22 Mar 2018 (actual)
Primary completion: 1 Aug 2022 (actual)
Study completion: 1 Aug 2022 (actual)
First posted: 17 Jan 2018 (actual)
Results: Posted 6 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active Treatment	Experimental	Device: Chordate System S211 in treatment mode
Sham Treatment	Sham comparator	Device: Chordate System S211 in placebo mode

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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 (inclusive) at the time of providing informed consent;
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);
Migraine onset before the age of 60 years;
Reported history of migraine for at least 1 year before screening;

Key exclusion criteria (16 listed)

Unable to distinguish between migraine headaches and other headache types;
Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chordate System S211 in treatment modeChordate System S211 in treatment mode	Device	Active Treatment
Chordate System S211 in placebo modeChordate System S211 in placebo mode	Device	Sham Treatment

Primary outcome

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
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.

17 secondary outcomes

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
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
MSQ - Role Function - Preventive
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
MSQ - Emotional Function
Time frame: Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)
Patient Global Impression of Severity (PGI-S)
Time frame: Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)
Incidence of Adverse Events (AEs)
Time frame: Days 0, 7, 14, 21, 28, 35, 42, 70

Results and safety

Results posted to the registry on 6 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	75	67
Sham Treatment	69	65

Primary outcome: 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. Least squares mean (Standard Error). Unit: change in days

Measure	Active Treatment n = 67	Sham Treatment n = 65
Value	-3.45 (0.62)	-1.22 (0.62)

Active Treatment vs Sham Treatment: Mean Difference (Final Values): -2.23 (95% CI -4.11 to -0.49), p = 0.0132, ANCOVA

Population analysed: FAS

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	1 of 76 (1.3%)	49 of 76 (64.5%)	0 of 76
Sham Treatment	0 of 68 (0%)	41 of 68 (60.3%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39787477Hoffmann J, Kaube H, Rimmele F, Jurgens TP, Nissila M, Gaul C, Kallela M, Keski-Santti P, Sumelahti ML, Straube A, Lewis D, Hoffmann V, Wirtz L, Rempel A, Bohm O, May A. Kinetic Oscillation Stimulation for the Preventive Treatment of Chronic Migraine: A Randomized, Double-Blind, Sham-Controlled Trial. Neurology. 2025 Feb 11;104(3):e210220. doi: 10.1212/WNL.0000000000210220. Epub 2025 Jan 9.
Individual participant dataSharing planned: 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.

Related trials for Chronic Migraine

Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arne May, Prof. Dr. principal investigator

Universitätsklinikum Hamburg-Eppendorf

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chordate System S211 in treatment mode in people with Chronic Migraine, run by Chordate Medical at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03400059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.