MigrainePhase 1VeronaNCT01855672

Occipital Nerve Stimulation in the Treatment of Migraine

A Phase 1 study testing Stimulation of the Occipital Nerves in people with Migraine, run by Ethicon, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of this proof-of-concept study is to generate initial safety and effectiveness data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in an acute setting. The results of this study will determine if further development of this device in a larger study is warranted. Read more about this study

Who is it for?: Ages 8 to 65 years
Conditions the study is for: Migraine
What is being tested?: Stimulation of the Occipital Nerves
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 4 sitesUnited States
Study dates: Apr 2013to Jul 2013
Phase: Phase 1
Are there results?: None posted in the registry

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 8 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Adult ≥ 18 and ≤ 65 years of age females or males;
Willing to participate in the study and to complete all study-related procedures, evaluations, and headache diaries;
Able to understand, agree to, and sign the study's IRB-approved informed consent form;
Has a physician-made diagnosis of Chronic Migraine as defined by the following (a, b, and c):
Headache (tension-type and/or migraine) lasting a minimum of 4 hours on ≥15 days per month for at least 3 months and on ≥XX (redacted by sponsor to preserve integrity of study) days in the 30 days prior to the Screening Visit;
Headaches on ≥8 days per month for at least 3 months that have fulfilled the following:

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Headaches with at least two of the following:
unilateral location;
pulsating quality;
moderate or severe pain intensity;
aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs);
AND at least one of the following:
nausea and/or vomiting;
photophobia and phonophobia;
OR headaches that have been treated and relieved by triptan(s) or ergot before the expected development of the symptoms listed in 4.b.i and 4.b.ii above;
Headaches are not attributed to a substance or substance withdrawal, infection, cranial neuralgias, cluster headaches, autonomic cephalalgias, or cranial, cervical vascular, non-vascular, intracranial homeostasis and psychiatric disorders;
If taking medication (prescribed or over-the-counter) for migraine prophylaxis, the medication must have been taken for at least 2 months and the dosage(s) must have been stable for at least 1 month prior to the Screening Visit. There must be no plan to add to, discontinue, or change the dose of these medications throughout the subject's participation in the study;
To be eligible for the inpatient Treatment Period: the subject must have recorded in the Headache Diary ≥XX (redacted by sponsor to preserve integrity of study) headaches days (at least 4 hours of continuous head pain per headache day) in the 30 days immediately prior to the Inpatient Treatment Eligibility Visit (Visit 2);
To be eligible for the inpatient Treatment Period: mean head pain severity of ≥XX (redacted by sponsor to preserve integrity of study) and ≤XX (redacted by sponsor to preserve integrity of study) based on the 11-point Numerical Rating Scale (NRS) in the 30 days immediately prior to the Inpatient Treatment Eligibility Visit (Visit 2) [only data from headache days will be used to calculate the mean head pain severity; missing data on a headache day will be considered to be zero (0) for this calculation]; and
To be eligible for the inpatient Treatment Period: The subject must be experiencing head pain on the day of the inpatient Treatment Eligibility Visit (Visit 2). Subjects may continue the Screening Period for another week if head pain is not present at Visit 2.

Who cannot join

Any head pain, including coexisting head pain, not attributable to Chronic Migraine as defined in this study's Inclusion Criterion #4;
Any condition that could affect the subject's ability to assess the effect of neurostimulation or in which neurostimulation may be a safety concern, including but not limited to:
Known history of epilepsy or recurrent seizures;
Known neurogenic and neuromuscular disorders (i.e. myasthenia gravis, multiple sclerosis, autonomic disorders);
Uncontrolled diabetes mellitus;
Known peripheral neuropathy;

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History of taking the following medications in the 30 days prior to the Screening Visit:
Opioid and opioid-containing medications;
Butalbital, butalbital-containing, and barbiturate medications;
Systemic corticosteroids (exceptions: acute corticosteroid medication including inhaled therapy (pulmonary), ocular therapy, or non-spinal intra-articular therapy);
Urine drug screen that is positive for any of the tested drugs (i.e., cannabis, opiates, barbiturates, amphetamines , benzodiazepines and cocaine) at the Screening Visit (Visit 1) and the Inpatient Treatment Eligibility Visit (Visit 2);
Positive pregnancy test at the Screening Visit (Visit 1) or at the Inpatient Treatment Eligibility Visit (Visit 2);
Known history of cardiac conduction or heart rate abnormalities associated with symptoms;
Uncontrolled hypertension;
Any tattoos or extensive tissue scarring in the cervical/occipital area;
Any active skin lesions, skin damage, broken skin, history of easy bruising or bleeding disorders, or history of surgery and/or trauma in the cervical/occipital area at the time of the Screening Visit;
History of occipital nerve (ON) block, peripheral ON stimulation, or botulinum toxin (e.g., Botox) for treatment of headaches within the 90 days prior to the Screening Visit;
Radiofrequency rhizolysis involving the occipital nerve or cervical nerves;
Surgery involving the occipital nerve or cervical nerves (e.g. neurectomy or rhizotomy), or cervical ganglionectomy;
History of craniotomy or intracranial surgery;
Presence of metallic implant (e.g., metal pin, staple, clip) in the skull or neck area;
Presence of any implanted neuromodulation or cardiac device;
Severe or uncontrolled psychiatric disorders (i.e. schizophrenia, depression, anxiety, or at investigator discretion);
Any other medical condition, concomitant medication or finding for which, at the discretion of the investigator, the subject should be excluded for reasons of safety or capacity for study compliance; or
Participation in any other clinical study (not to include registries or survey-only studies) within 30 days or 5 half lives of an investigational drug, whichever is longer, of Visit 1 (Screening Visit) and for the duration of the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Community Research
Cincinnati, Ohio
Clinilabs
New York, New York
ActivMed
Newington, New Hampshire
TJU
Philadelphia, Pennsylvania

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Controlled, Double-Blind, Proof-of-Concept Study Assessing the Safety and Effectiveness of a Signal Generator Device (NMS EBox) for the Treatment of Chronic Migraine

Conditions: Migraine
Being tested: Stimulation of the Occipital Nerves
Keywords: Migraine, occipital nerve, stimulation
Medical subject headings: Migraine Disorders

What participants receive

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

Stimulation of the Occipital NervesDevice
Electrical stimulation of the occipital nerves.

Study groups in NCT01855672
Study group	Role	What they receive
Perceivable Stimulation	Active comparator	Stimulation of the occipital nerves. Receives: Device: Stimulation of the Occipital Nerves
Non-Perceivable	Active comparator	Stimulation of the occipital nerves. Receives: Device: Stimulation of the Occipital Nerves

What is being measured

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

Reduction of Head Pain Severity
The primary endpoint is overall reduction of head pain severity in subjects with chronic migraine who are treated with the NMS E-Box over a 96-hour treatment period.
Measured: Over 96-hours treatment period

Secondary outcomes (11)

Rates of Reduction in Severity of Head Pain
Responder rates for reduction in the severity of head pain associated with chronic migraine over the 96-hour Treatment Period (e.g., 30% and 50% responder rates).
Measured: Over the 96-hour treatment period
Time with No Head Pain
Increase in cumulative time with no head pain over the 96-hour Treatment Period.
Measured: Over the 96-hour Treatment Period
Presence of Symptoms
Decrease in the presence of each of the following migraine-associated symptoms (i.e., nausea or vomiting; photophobia; phonophobia) over the 96-hour Treatment Period.
Measured: Over the 96-hour treatment period
Severity of Symptoms
Decrease in the severity of each of the following migraine-associated symptoms (i.e., nausea or vomiting; photophobia; phonophobia) over the 96-hour Treatment Period.
Measured: Over the 96-hour treatment period
Use of Medication
Decrease in the use of any over-the-counter or prescription medication taken for the acute treatment of migraine or head pain over the 96-hour Treatment Period.
Measured: Over the 96-hour treatment period
Impairment
Decrease in Migraine-Related Impairment over the 96-hour Treatment Period.
Measured: Over the 96-hour treatment period
Sleep Quality
Improvement in Sleep Quality over the 96-hour Treatment Period.
Measured: Over the 96-hour treatment period
PGIC
Improvement in the Patient Global Impression of Change (PGIC) for Chronic Migraine at the end of the 96-hour Treatment Period.
Measured: End of the 96-hour treatment period
CGIC
Improvement in the Clinician Global Impression of Change (CGIC) for Chronic Migraine at the end of the 96-hour Treatment Period.
Measured: End of the 96-hour treatment period
PGIC Migraine
Improvement in the Patient Global Impression of Change for Migraine-Related Impairment at the end of the 96-hour Treatment Period.
Measured: End of the 96-hour treatment period
PGIC Sleep
Improvement in the Patient Global Impression Change for Sleep Quality at the end of the 96-hour Treatment Period.
Measured: End of the 96-hour treatment period

Timeline

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

Apr 2013Jul 2013

First posted16 May 2013 (estimated)
Study startApr 2013
Primary completionJul 2013
Study completionJul 2013

Why it stopped: Business strategic decision not related to safety.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01855672
Sponsor's protocol ID: ESC-13-001
Acronym: Verona
Status last verified: Jun 2013
First submitted: 14 May 2013
Last updated: 17 Jul 2013
Results posted: No
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
Migraine
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
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Controlled, Double-Blind, Proof-of-Concept Study Assessing the Safety and Effectiveness of a Signal Generator Device (NMS EBox) for the Treatment of Chronic Migraine
ClinicalTrials.gov ID: NCT01855672
Acronym / sponsor ID: Verona / ESC-13-001
Conditions: Migraine
Keywords: Migraine, occipital nerve, stimulation
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business strategic decision not related to safety.
Enrolment: 1 participants (actual)
Lead sponsor: Ethicon, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 16 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Perceivable Stimulation	Active comparator	Device: Stimulation of the Occipital NervesStimulation of the occipital nerves.
Non-Perceivable	Active comparator	Device: Stimulation of the Occipital NervesStimulation of the occipital nerves.

Who may qualify

Ages: 8 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

Adult ≥ 18 and ≤ 65 years of age females or males;
Willing to participate in the study and to complete all study-related procedures, evaluations, and headache diaries;
Able to understand, agree to, and sign the study's IRB-approved informed consent form;
Has a physician-made diagnosis of Chronic Migraine as defined by the following (a, b, and c):
If taking medication (prescribed or over-the-counter) for migraine prophylaxis, the medication must have been taken for at least 2 months and the dosage(s) must have been stable for at least 1 month prior to the Screening Visit. There must be no plan to add to, discontinue, or change the dose of these medications throughout the subject's participation in the study;

Key exclusion criteria (25 listed)

Any head pain, including coexisting head pain, not attributable to Chronic Migraine as defined in this study's Inclusion Criterion #4;
Any condition that could affect the subject's ability to assess the effect of neurostimulation or in which neurostimulation may be a safety concern, including but not limited to:
History of taking the following medications in the 30 days prior to the Screening Visit:
Urine drug screen that is positive for any of the tested drugs (i.e., cannabis, opiates, barbiturates, amphetamines , benzodiazepines and cocaine) at the Screening Visit (Visit 1) and the Inpatient Treatment Eligibility Visit (Visit 2);
Positive pregnancy test at the Screening Visit (Visit 1) or at the Inpatient Treatment Eligibility Visit (Visit 2);

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
Stimulation of the Occipital NervesElectrical stimulation of the occipital nerves.	Device	Non-Perceivable, Perceivable Stimulation

Primary outcome

Reduction of Head Pain Severity
Time frame: Over 96-hours treatment period
The primary endpoint is overall reduction of head pain severity in subjects with chronic migraine who are treated with the NMS E-Box over a 96-hour treatment period.

11 secondary outcomes

Rates of Reduction in Severity of Head Pain
Time frame: Over the 96-hour treatment period
Time with No Head Pain
Time frame: Over the 96-hour Treatment Period
Presence of Symptoms
Time frame: Over the 96-hour treatment period
Severity of Symptoms
Time frame: Over the 96-hour treatment period
Use of Medication
Time frame: Over the 96-hour treatment period
Impairment
Time frame: Over the 96-hour treatment period
Sleep Quality
Time frame: Over the 96-hour treatment period
PGIC
Time frame: End of the 96-hour treatment period
CGIC
Time frame: End of the 96-hour treatment period
PGIC Migraine
Time frame: End of the 96-hour treatment period
PGIC Sleep
Time frame: End of the 96-hour treatment period

Results and safety

The study was stopped early (reason given: Business strategic decision not related to safety.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.

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
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
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.

David Biondi, DO study director

Janssen, LP

Jeff Hammond, MD study director

Ethicon, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stimulation of the Occipital Nerves in people with Migraine, run by Ethicon, Inc. at 4 sites 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 20 inclusion and 25 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: stopped early, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business strategic decision not related to safety.). Results are not available in the source record.

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?

Reduction of Head Pain Severity (time frame: Over 96-hours treatment period). 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 NCT01855672.

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 17 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.