Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

A study testing CEFALY in people with Migraine, run by Cefaly Technology at 1 site in United States.

Completed

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

Trial summary

The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: CEFALY
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteUnited States
Study dates: 2 Feb 2015to 11 Apr 2017
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

Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.
Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited

Who cannot join

Women: Pregnant, lactating or <6 months post partum
For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
A Beck Depression Inventory score of >24 at baseline
Psychiatric disorders that could have interfered with study participation
Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Anschutz Medical Campus - Department of Neurology
Aurora, Colorado, 80045

Other trials in United States

About this study

The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

Read the detailed description

The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

Conditions: Migraine
Being tested: CEFALY
Medical subject headings: Migraine Disorders

What participants receive

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

CEFALYDevice

Study groups in NCT02342743
Study group	Role	What they receive
Active	Experimental	Daily trigeminal nerve stimulation session of 20 minutes with CEFALY Receives: Device: CEFALY

What is being measured

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

Change From Baseline in Frequency of Headache Days
Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of baseline period and end of 12 weeks treatment period
Change From Baseline in Acute Medication Intake
Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of baseline period and end of 12 weeks treatment period

Secondary outcomes (6)

Change in Frequency of Migraine Days
Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of baseline period and end of 12 weeks treatment period
Change in Frequency of Moderate/Severe Headache Days
Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of baseline period and end of 12 weeks treatment period
Change in Monthly Cumulative Headache Hours
Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of baseline period and end of 12 weeks treatment period
Change in Frequency of Headache Episodes
Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of baseline period and end of 12 weeks treatment period
50% Responder Rate for Migraine Days
Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Measured: End of the 12 weeks treatment period
Change in the Average Headache Intensity
Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain).
Measured: End of baseline period and end of 12 weeks treatment period

Timeline

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

2 Feb 201511 Apr 2017

First posted21 Jan 2015 (estimated)
Study start2 Feb 2015
Primary completion11 Apr 2017
Study completion11 Apr 2017

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.
Other trials for 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02342743
Sponsor's protocol ID: 50207
Status last verified: Jun 2019
First submitted: 15 Jan 2015
Last updated: 20 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
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Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
Marine Lipids Ease Painful TMD
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
ClinicalTrials.gov ID: NCT02342743
Acronym / sponsor ID: 50207
Conditions: Migraine
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Cefaly TechnologyIndustry (pharma, biotech, devices)
Study start: 2 Feb 2015 (actual)
Primary completion: 11 Apr 2017 (actual)
Study completion: 11 Apr 2017 (actual)
First posted: 21 Jan 2015 (estimated)
Results: Posted 19 Sep 2018

Clinical summary

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

The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active	Experimental	Device: CEFALYDaily trigeminal nerve stimulation session of 20 minutes with CEFALY

Who may qualify

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

Key inclusion criteria (2 listed)

Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.
Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited

Key exclusion criteria (7 listed)

Women: Pregnant, lactating or <6 months post partum
For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
A Beck Depression Inventory score of >24 at baseline

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
CEFALY	Device	Active

Primary outcome

Change From Baseline in Frequency of Headache Days
Time frame: End of baseline period and end of 12 weeks treatment period
Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Change From Baseline in Acute Medication Intake
Time frame: End of baseline period and end of 12 weeks treatment period
Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.

6 secondary outcomes

Change in Frequency of Migraine Days
Time frame: End of baseline period and end of 12 weeks treatment period
Change in Frequency of Moderate/Severe Headache Days
Time frame: End of baseline period and end of 12 weeks treatment period
Change in Monthly Cumulative Headache Hours
Time frame: End of baseline period and end of 12 weeks treatment period
Change in Frequency of Headache Episodes
Time frame: End of baseline period and end of 12 weeks treatment period
50% Responder Rate for Migraine Days
Time frame: End of the 12 weeks treatment period
Change in the Average Headache Intensity
Time frame: End of baseline period and end of 12 weeks treatment period

Results and safety

Results posted to the registry on 19 Sep 2018, 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	73	58

Primary outcome: Change From Baseline in Frequency of Headache Days

Time frame: End of baseline period and end of 12 weeks treatment period. Mean (Standard Deviation). Unit: days per 28-days

Measure	Active n = 58
Value	-3.12 (5.70)

Active: p <0.001, Wilcoxon (Mann-Whitney)

Primary outcome: Change From Baseline in Acute Medication Intake

Time frame: End of baseline period and end of 12 weeks treatment period. Mean (Standard Deviation). Unit: medications per 28-days

Measure	Active n = 58
Value	-8.11 (18.74)

Active: p <0.001, Wilcoxon (Mann-Whitney)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	1 of 58 (1.7%)	26 of 58 (44.8%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

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.

Marius Birlea, MD principal investigator

Department of Neurology, University of Colorado Anschutz Medical Campus

Pierre Rigaux study director

Cefaly Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CEFALY in people with Migraine, run by Cefaly Technology at 1 site in United States.

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 2 inclusion and 7 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 19 Sep 2018). 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?

Change From Baseline in Frequency of Headache Days (time frame: End of baseline period and end of 12 weeks treatment period). The study lists 2 primary outcomes in all. 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 NCT02342743.

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 20 Jun 2019.