Migraine Without AuraNCT03361423
Evaluation of a Novel Device for Treatment of Migraine Headache
A study testing Nerivio Migra-1 active device in people with Migraine Without Aura and Migraine With Aura, run by Theranica at 12 sites in 2 countries.
Trial summary
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine Without Aura, Migraine With Aura
- What is being tested?
- Nerivio Migra-1 active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 17 Dec 2017to 25 Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18-75 years old.
- Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
- Subjects report 2-8 migraine attacks per month.
- Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
- Subjects must be able and willing to comply with the protocol
- Subjects must be able and willing to provide written informed consent
Who cannot join
- Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
- Subject has an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
- Subject has known uncontrolled epilepsy.
- Any use of Cannabis including medical use.
- Subject has >10 headache days per month.
- Subject has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
Show all 13Show fewer
- Subject is participating in any other clinical study.
- The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
- Pregnant, or trying to get pregnant
- Subject is experiencing a menstrually related migraine
- Received OnabotulinumtoxinA or any botulinum toxin injections for migraine within the previous month
- Received parenteral infusions for migraine within the previous 2 weeks.
- Subject participated in a previous study with the Nerivio Migra 1 device
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States7 sites
Hartford Headache Center
Hartford, Connecticut, 06107
Clinical Reseach Consortium
Las Vegas, Nevada, 89119
Northwell Health, Inc
New York, New York, 11042
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Rochester Clinical Research
Rochester, New York, 14609
Clinvest Research
Springfield, Missouri, 65810
Mercy Hospital
St Louis, Missouri, 63141
Israel5 sites
Rambam Medical Center
Haifa
wolfson Medical Center
Holon, 58100
Meir Medical Center
Kfar Saba, 4428164
Belinson Medical Center
Petah Tikva, 4941492
Souraskyr Medical center - Ichilov
Tel Aviv
About this study
Official title: A Randomized, Double Blinded, Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1, a Neuromodulation Device, for the Acute Treatment of Migraine
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment.
Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects.
Read more
The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere.
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura.
The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts.
The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
Read the detailed description
Nerivio Migra is intended for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is self-applied to the upper arm. Treatments are self-administered by the user at the onset of a migraine attack. The device delivers extra cephalic transcutaneous electrical stimulation below the pain threshold to the skin of the upper arm at the onset of a migraine attack. Nerivio Migra is operated via a mobile application.
This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial to test the ability of the Nerivio Migra neuromodulation device to relieve the patient's migraine pain during a migraine attack. The study will enroll up to 270 patients diagnosed with migraine with or without aura, per the inclusion and exclusion criteria. These patients will be individually and randomly assigned to either treatment group or control group. For sham control, electrical pulses of similar width and intensity, but much lower frequency compared to the active device will be administered. This sham program produces pulses that are perceivable by the user, thus maintaining the blinding, but on the other hand do not have therapeutic qualities, based on existing knowledge of parameters range of electro stimulation treatments.
- st visit - screening, enrollment and training on the application in diary mode Following successful screening, enrollment interview and signing of informed consent, participants will be provided with the Nerivio Migra application (either installed on their own smartphone, or on a smartphone provided by the study coordinator). The participants will be trained how to operate the application and report their migraine attacks in the patient diary mode, which is part of the application. The site personnel will be required to approve the training session in the CRF. Stage 1 - Roll in phase The Roll-in is a period of 15 - 30 days in which at least two (2) and no more of eight (8) migraine attacks has been occurred. During this period, baseline information including mean frequency and severity of migraine attacks, occurrence of other headaches, presence of ICHD-3 diagnostic criteria for migraine with or without aura and use of preventive and rescue medications will be recorded.
- nd visit Following the Roll-in phase, the participants will arrive to the clinic and their compliance to the study procedures and eligibility to continue to the next phase will assessed.
Participants that will be eligible to continue to the treatment phase will undergo the following:
- Participant will be randomized into one of the two study group (Active or Sham device) Investigational devices will be programmed in active or sham mode with a 1:1 ratio, in order to achieve the desired ratio between active and control groups sizes, stratified with by use of preventive medications.
- Participant will be trained on the device, the application (in diary and treatment modes), the treatment procedures and the key elements critical for the success of the study:
- Apply the Nerivio Migra as soon as possible following the onset of the migraine symptoms and NO LATER than 60 min from onset
- Refrain from taking any rescue medication 2 hours following the start of treatment.
- Perform the treatment for a period of at least 30 minutes (recommended treatment time is 45 minutes).
Stage 2 - Parallel arms, double- blind treatment phase. Participants will be instructed to activate the device at onset of a qualifying migraine attack and manually adjust stimulation intensity to a level within the pre-defined range, where it is well perceived but not painful. A qualifying migraine attack shall be preceded by at least 48 hours of freedom from migraine. Patients will be requested to refrain from use of rescue medications prior to and during the first two hours after treatment with the device, and if they cannot comply with this, record their use of rescue medications (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list) in the mobile application.
Via the smartphone application, each participant will be asked to rate his/her migraine pain level three times using Pain Grades Scale (0 - no pain, 1- mild pain, 2- moderate pain, 3 - severe pain): (1) upon starting the treatment, (2) two hours after start of treatment, (3) 48 hours after start of attack. At the start of each treatment, participants will be also asked to provide time elapsed from start of migraine symptoms to start of the treatment. Participants will be also asked to provide feedback regarding their use of medication (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list), presence of nausea, photophobia, phonophobia or allodynia, and treatment perception. After providing feedback at two hours after start of treatment and in case of pain recurrence, participants will be allowed to re-treat the attack using Nerivio Migra device.
Adverse events will be reported.
Stage 3 (optional, by subject request only) - Open label extended treatment:
Following the completion of double-blind stage of the study, all subjects will be offered a 2-month open label period using the active device.
- Conditions
- Migraine Without Aura, Migraine With Aura
- Being tested
- Nerivio Migra-1 active device, Nerivio Migra-1 Sham device
- Medical subject headings
- Migraine without Aura, Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerivio Migra-1 active deviceDevice
The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
Nerivio Migra-1 Sham deviceDevice
The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
| Study group | Role | What they receive |
|---|---|---|
| treatment of migraine with active device | Active comparator | Treatment of acute migraine with an active form of Nerivio migra-1 device Receives: Device: Nerivio Migra-1 active device |
| treatment of migraine with sham device | Sham comparator | Treatment of acute migraine with a sham form of the Nerivio Migra-1 device Receives: Device: Nerivio Migra-1 Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment
The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
Measured: 2 hours post migraine onset
Secondary outcomes (3)
Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment
The percentage of patients reporting, 2 hours post-treatment, freedom from their most bothersome migraine-associated symptom (MBS) other than a headache, in their first treated migraine attack (excluding the "run-in test" treatment). MBS may be nausea, photophobia, phonophobia or allodynia - as defined by each subject at the beginning of the treatment
Measured: 2 hours post migraine onset
Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment
The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints
Measured: 2 hours post migraine onset
Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment
The percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack
Measured: 2 hours post migraine onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start17 Dec 2017
- Primary completion25 Nov 2018
- Study completion25 Dec 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for Migraine Without AuraStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, double blinded, sham controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus, Northwell Health
- Responsible party
- Sponsor
- Investigators
- David Yarnitsky, Prof, Study director, Rambam Medical Center, IsraelMoris Levin, MD, Study chair, University California Sun Francisco, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361423
- Sponsor's protocol ID
- TCH003
- Status last verified
- Feb 2019
- First submitted
- 18 Nov 2017
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rapoport AM, Bonner JH, Lin T, Harris D, Gruper Y, Ironi A, Cowan RP. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. 2019 Jul 22;20(1):83. doi: 10.1186/s10194-019-1033-9.
PubMed 31331265Yarnitsky D, Dodick DW, Grosberg BM, Burstein R, Ironi A, Harris D, Lin T, Silberstein SD. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. 2019 Sep;59(8):1240-1252. doi: 10.1111/head.13551. Epub 2019 May 9.
PubMed 31074005
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1, a Neuromodulation Device, for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT03361423
- Acronym / sponsor ID
- TCH003
- Conditions
- Migraine Without Aura, Migraine With Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus, Northwell Health
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment.
Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects.
The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere.
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura.
The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts.
The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
Detailed description
Nerivio Migra is intended for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is self-applied to the upper arm. Treatments are self-administered by the user at the onset of a migraine attack. The device delivers extra cephalic transcutaneous electrical stimulation below the pain threshold to the skin of the upper arm at the onset of a migraine attack. Nerivio Migra is operated via a mobile application.
This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial to test the ability of the Nerivio Migra neuromodulation device to relieve the patient's migraine pain during a migraine attack. The study will enroll up to 270 patients diagnosed with migraine with or without aura, per the inclusion and exclusion criteria. These patients will be individually and randomly assigned to either treatment group or control group. For sham control, electrical pulses of similar width and intensity, but much lower frequency compared to the active device will be administered. This sham program produces pulses that are perceivable by the user, thus maintaining the blinding, but on the other hand do not have therapeutic qualities, based on existing knowledge of parameters range of electro stimulation treatments.
- st visit - screening, enrollment and training on the application in diary mode Following successful screening, enrollment interview and signing of informed consent, participants will be provided with the Nerivio Migra application (either installed on their own smartphone, or on a smartphone provided by the study coordinator). The participants will be trained how to operate the application and report their migraine attacks in the patient diary mode, which is part of the application. The site personnel will be required to approve the training session in the CRF. Stage 1 - Roll in phase The Roll-in is a period of 15 - 30 days in which at least two (2) and no more of eight (8) migraine attacks has been occurred. During this period, baseline information including mean frequency and severity of migraine attacks, occurrence of other headaches, presence of ICHD-3 diagnostic criteria for migraine with or without aura and use of preventive and rescue medications will be recorded.
- nd visit Following the Roll-in phase, the participants will arrive to the clinic and their compliance to the study procedures and eligibility to continue to the next phase will assessed.
Participants that will be eligible to continue to the treatment phase will undergo the following:
- Participant will be randomized into one of the two study group (Active or Sham device) Investigational devices will be programmed in active or sham mode with a 1:1 ratio, in order to achieve the desired ratio between active and control groups sizes, stratified with by use of preventive medications.
- Participant will be trained on the device, the application (in diary and treatment modes), the treatment procedures and the key elements critical for the success of the study:
- Apply the Nerivio Migra as soon as possible following the onset of the migraine symptoms and NO LATER than 60 min from onset
- Refrain from taking any rescue medication 2 hours following the start of treatment.
- Perform the treatment for a period of at least 30 minutes (recommended treatment time is 45 minutes).
Stage 2 - Parallel arms, double- blind treatment phase. Participants will be instructed to activate the device at onset of a qualifying migraine attack and manually adjust stimulation intensity to a level within the pre-defined range, where it is well perceived but not painful. A qualifying migraine attack shall be preceded by at least 48 hours of freedom from migraine. Patients will be requested to refrain from use of rescue medications prior to and during the first two hours after treatment with the device, and if they cannot comply with this, record their use of rescue medications (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list) in the mobile application.
Via the smartphone application, each participant will be asked to rate his/her migraine pain level three times using Pain Grades Scale (0 - no pain, 1- mild pain, 2- moderate pain, 3 - severe pain): (1) upon starting the treatment, (2) two hours after start of treatment, (3) 48 hours after start of attack. At the start of each treatment, participants will be also asked to provide time elapsed from start of migraine symptoms to start of the treatment. Participants will be also asked to provide feedback regarding their use of medication (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list), presence of nausea, photophobia, phonophobia or allodynia, and treatment perception. After providing feedback at two hours after start of treatment and in case of pain recurrence, participants will be allowed to re-treat the attack using Nerivio Migra device.
Adverse events will be reported.
Stage 3 (optional, by subject request only) - Open label extended treatment:
Following the completion of double-blind stage of the study, all subjects will be offered a 2-month open label period using the active device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective, randomized, double blinded, sham controlled study
| Arm | Type | Receives |
|---|---|---|
| treatment of migraine with active device | Active comparator | Device: Nerivio Migra-1 active deviceTreatment of acute migraine with an active form of Nerivio migra-1 device |
| treatment of migraine with sham device | Sham comparator | Device: Nerivio Migra-1 Sham deviceTreatment of acute migraine with a sham form of the Nerivio Migra-1 device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age 18-75 years old.
- Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
- Subjects report 2-8 migraine attacks per month.
- Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
- Subjects must be able and willing to comply with the protocol
Key exclusion criteria (13 listed)
- Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
- Subject has an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
- Subject has known uncontrolled epilepsy.
- Any use of Cannabis including medical use.
- Subject has >10 headache days per month.
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 |
|---|---|---|
| Nerivio Migra-1 active deviceThe device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site. | Device | treatment of migraine with active device |
| Nerivio Migra-1 Sham deviceThe device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus. | Device | treatment of migraine with sham device |
Primary outcome
Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment
Time frame: 2 hours post migraine onset
The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
3 secondary outcomes
Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment
Time frame: 2 hours post migraine onset
Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment
Time frame: 2 hours post migraine onset
Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment
Time frame: 2 hours post migraine onset
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31331265Rapoport AM, Bonner JH, Lin T, Harris D, Gruper Y, Ironi A, Cowan RP. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. 2019 Jul 22;20(1):83. doi: 10.1186/s10194-019-1033-9.
- Derived from this study: PubMed 31074005Yarnitsky D, Dodick DW, Grosberg BM, Burstein R, Ironi A, Harris D, Lin T, Silberstein SD. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. 2019 Sep;59(8):1240-1252. doi: 10.1111/head.13551. Epub 2019 May 9.
- Individual participant dataSharing planned: Undecided
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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.
David Yarnitsky, Prof study director
Rambam Medical Center, Israel
Moris Levin, MD study chair
University California Sun Francisco, USA
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerivio Migra-1 active device in people with Migraine Without Aura and Migraine With Aura, run by Theranica at 12 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 6 inclusion and 13 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Israel. 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 19 May 2021). 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?
Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment (time frame: 2 hours post migraine onset). 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 NCT03361423, which also lists 2 linked publications.
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 19 May 2021.