An interventional study of Nerivio Migra-1 active device and Nerivio Migra-1 Sham device in Migraine Without Aura and Migraine With Aura, sponsored by Theranica. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by Theranica · Not applicable, Interventional, and Treatment
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Among 31 studies in Migraine without Aura with a site in United States — 6 open to participants now, 7 under way, none of them phase 3. Migraine without Aura · United States.
Among the 31 studies in Migraine without Aura with a site in United States, this one is the 7th largest by enrollment of the 30 interventional ones that give a count, is one of 5 that started in 2017, is one of 15 with no phase, and was the 14th registered.
109 studies on the registry are indexed under Migraine without Aura; 18 are open to participants now.
Browse Migraine without Aura studies →6 of the 31 studies in Migraine without Aura with a site in United States are open now. Recruiting first, the newest first:
University of South Florida · Sites in United States
Ages 18+ · Healthy volunteers
Evommune, Inc. · Sites in United States, Australia, Canada and 1 more country
Ages 18–64
Wake Forest University Health Sciences · Sites in United States
Ages 18+
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 10–17
Hinge Health, Inc · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Migraine without Aura studies recruiting now, 5 (42%) set no upper age limit and 7 (58%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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31 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 296 is above the median of 87 across 87 interventional studies indexed under Migraine without Aura.
Median enrollment 96 across the 30 interventional studies. Of the 20 that completed or were terminated, 9 (45%) have results posted.
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14 of 31 have an industry lead sponsor. The 10 most frequent:
Theranica is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Theranica has 2 studies filed under Migraine without Aura — fewer than ten, so there is no comparison to draw.
4 of the studies in Migraine without Aura with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05987592Wake Forest University Health SciencesBE WELL With Migraine: Brain Education and WELLness With Migraine | 2027-06-30 |
| NCT07667621University of South FloridaA Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department | 2027-07 |
| NCT05889624Children's Hospital Medical Center, CincinnatiResponding With Evidence and Access for Childhood Headaches | 2027-07-31 |
| NCT07616128Evommune, Inc.Study of EVO756 in Adults With Migraine | 2027-10 |
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Among the 31 studies in Migraine without Aura with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Participants that will be eligible to continue to the treatment phase will undergo the following:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment of acute migraine with an active form of Nerivio migra-1 device
Device: Nerivio Migra-1 active device
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Device: Nerivio Migra-1 Sham device
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.
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.
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).
Time frame: 2 hours post migraine onset
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
Time frame: 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
Time frame: 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
Time frame: 2 hours post migraine onset
Number of Adverse Events Related or Unrelated to the Study Device
The number of Adverse events related to the study device. Safety analyses were performed on all participants from the ITT population (126 participants in each group).
Time frame: up to 14 weeks
Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments
The repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks (excluding the run-in attack
Time frame: up to 6 weeks
Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device
The proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
Time frame: 48 hours post treatment
Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the Device
The proportion (%) of subjects reporting treatment response 2 hours post-treatment without rescue medications, and no return to baseline level of pain at time of treatment, or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
Time frame: 48 hours post treatment
| Milestone | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Started | 126 | 126 |
| Completed | 99 | 103 |
| Not completed | 27 | 23 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Did not treat | 19 | 18 |
| Withdrew: Started >60 minutes from migraine onset | 0 | 1 |
| Withdrew: Missing data | 4 | 1 |
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).
| Participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment | 66 | 40 |
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
| Participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment | 44 | 22 |
The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints
| Participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment | 38 | 15 |
The percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack
| Participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment | 37 | 19 |
The number of Adverse events related to the study device. Safety analyses were performed on all participants from the ITT population (126 participants in each group).
| Adverse event | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Number of Adverse Events Related or Unrelated to the Study Device | 14 | 9 |
The repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks (excluding the run-in attack
| percentage of participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments | 51.3 (42.8 to 61.4) | 38.1 (31.2 to 46.6) |
The proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
| Participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device | 18 | 6 |
The proportion (%) of subjects reporting treatment response 2 hours post-treatment without rescue medications, and no return to baseline level of pain at time of treatment, or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
| Participants | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the Device | 32 | 14 |
Collected over up to 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment of Migraine With Active Device | 0/126 (0%) | 0/126 (0%) | 14/126 (11.1%) |
| Treatment of Migraine With Sham Device | 0/126 (0%) | 0/126 (0%) | 9/126 (7.1%) |
| Event | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Sensation of warmthSkin and subcutaneous tissue disorders | 6/126 | 3/126 |
| TinglingProduct Issues | 0/126 | 3/126 |
| Numbness of the armNervous system disorders | 2/126 | 0/126 |
| Pain in the armNervous system disorders | 2/126 | 0/126 |
| Redness of the skin at the treatment areaSkin and subcutaneous tissue disorders | 2/126 | 1/126 |
| Neck and shoulder painProduct Issues | 0/126 | 2/126 |
| Muscle spasmNervous system disorders | 1/126 | 0/126 |
| ItchingSkin and subcutaneous tissue disorders | 1/126 | 0/126 |
| Age, Continuous(years) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| Mean | 43.8 ± 12.25 | 41.6 ± 11.81 | 42.7 ± 12.06 |
| Sex: Female, Male(Participants) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| Female | 101 | 102 | 203 |
| Male | 25 | 24 | 49 |
| Race (NIH/OMB)(Participants) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 10 | 8 | 18 |
| White | 109 | 112 | 221 |
| More than one race | 4 | 5 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| United States | 90 | 85 | 175 |
| Israel | 36 | 41 | 77 |
| Average number of migraines attacks per month(Attacks per month) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| Mean | 5.2 ± 1.95 | 5.3 ± 1.90 | 5.3 ± 1.92 |
| Average number of migraine days per month(Days per month) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| Mean | 6.6 ± 2.43 | 6.6 ± 2.41 | 6.6 ± 2.40 |
| Use of preventive medication(Participants) | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| Count of participants | 36 | 46 | 82 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Nov 2018, 11 months.
Results were first posted in May 2021, 2 years 5 months after primary completion.
Of 33 interventional studies with no phase under Migraine without Aura, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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