An interventional study of Verum Cefaly® Abortive Program device and Sham Cefaly® Abortive Program device in Migraine, sponsored by Cefaly Technology. Completed at 10 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Cefaly Technology · Not applicable, Interventional, and Treatment
Among 696 studies in Migraine Disorders with a site in United States — 93 open to participants now, 115 under way, 27 of them phase 3. Migraine Disorders · United States.
Among the 696 studies in Migraine Disorders with a site in United States, this one is the 91st largest by enrollment of the 609 interventional ones that give a count, is one of 27 that started in 2018, is one of 203 with no phase, and was the 376th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →93 of the 696 studies in Migraine Disorders with a site in United States are open now. Recruiting first, the newest first:
Salvia BioElectronics · Sites in United States
Ages 22–84
University of Colorado, Denver · Sites in United States
Ages 12–17
Columbia University · Sites in United States
Ages 18–55
TriGemX Bio, Inc. · Sites in United States
Ages 18–75
University of North Carolina, Chapel Hill · 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 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
696 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 66 · Phase 2 113 · Phase 3 151 · Phase 4 101
First in 1999; this study’s year is marked. 27 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 607 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 78 across the 609 interventional studies, 195 across the 84 observational. Of the 526 that completed or were terminated, 305 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
344 of 696 have an industry lead sponsor. The 10 most frequent:
Cefaly Technology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Cefaly Technology has 7 studies filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
47 of the studies in Migraine Disorders with a site in United States that are under way reach primary completion within a year, 11 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06641466Phase 3PfizerA Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | 2026-11-29 |
| NCT07645924Phase 3TriGemX Bio, Inc.A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine | 2027-02 |
| NCT05598723Phase 3Naval Medical Center Camp LejeuneBOTOX® vs. XEOMIN® for Chronic Migraine | 2027-02-24 |
| NCT07018700Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine | 2027-03 |
| NCT07018713Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine | 2027-03 |
Add all 47 to your calendar (.ics) → With an account.
Among the 696 studies in Migraine Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.
The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Device: Verum Cefaly® Abortive Program device
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Device: Sham Cefaly® Abortive Program device
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
Pain Freedom at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Time frame: 2 hours
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Time frame: 2 hours
Pain Relief at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Time frame: 2 hours
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
Time frame: 2 hours
Use of Rescue Medication Between 2 and 24 Hours
The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
Time frame: 2-24 hours
Sustained Pain Freedom at 24 Hours
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Time frame: 24 hours
Sustained Pain Relief at 24 Hours
The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Time frame: 2-24 hours
Between April 10, 2018 and January 11, 2019, 626 subjects were screened for eligibility, and 607 were enrolled across ten centers in the United States.
| Milestone | Verum | Sham |
|---|---|---|
| Started | 299 | 308 |
| Completed | 259 | 279 |
| Not completed | 40 | 29 |
| Withdrew: Withdrawal by subject | 9 | 5 |
| Withdrew: Lost to follow-up | 11 | 9 |
| Withdrew: Protocol violation | 20 | 15 |
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
| Participants | Verum | Sham |
|---|---|---|
| Pain Freedom at 2 Hours | 66 | 51 |
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
| Participants | Verum | Sham |
|---|---|---|
| Most Bothersome Migraine-associated Symptom Freedom at 2 Hours | 146 | 118 |
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
| Participants | Verum | Sham |
|---|---|---|
| Pain Relief at 2 Hours | 180 | 154 |
The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
| Participants | Verum | Sham |
|---|---|---|
| Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours | 110 | 95 |
The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
| Participants | Verum | Sham |
|---|---|---|
| Use of Rescue Medication Between 2 and 24 Hours | 82 | 105 |
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
| Participants | Verum | Sham |
|---|---|---|
| Sustained Pain Freedom at 24 Hours | 59 | 44 |
The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
| Participants | Verum | Sham |
|---|---|---|
| Sustained Pain Relief at 24 Hours | 119 | 96 |
Collected over The data was collected during the 24 hours following the beginning of the treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Verum | 0/298 (0%) | 0/298 (0%) | 22/259 (8.5%) |
| Sham | 0/303 (0%) | 1/303 (0.3%) | 8/279 (2.9%) |
| Event | Verum | Sham |
|---|---|---|
| Appendicitis leading to appendectomySurgical and medical procedures | 0/298 | 1/303 |
| Event | Verum | Sham |
|---|---|---|
| Forehead paresthesias, discomfort, or burningNervous system disorders | 9/259 | 1/279 |
| Nausea / VomitingNervous system disorders | 4/259 | 0/279 |
| Worsened HeadacheNervous system disorders | 2/259 | 0/279 |
| Excessive SweatingNervous system disorders | 2/259 | 0/279 |
| DizzinessNervous system disorders | 1/259 | 2/279 |
| Neck Stiffness / Muscle tensionNervous system disorders | 1/259 | 2/279 |
| Abdominal Discomfort or CrampingEar and labyrinth disorders | 0/259 | 2/279 |
| Orodynia - tooth or jaw painSkin and subcutaneous tissue disorders | 1/259 | 1/279 |
| RestlessnessNervous system disorders | 1/259 | 1/279 |
| Dry MouthNervous system disorders | 1/259 | 0/279 |
| Age, Continuous(years) | Verum | Sham | Total |
|---|---|---|---|
| Mean | 40.22 ± 11.62 | 42.0 ± 12.30 | 41.14 ± 12.00 |
| Sex: Female, Male(Participants) | Verum | Sham | Total |
|---|---|---|---|
| Female | 214 | 229 | 443 |
| Male | 45 | 50 | 95 |
| Race and Ethnicity Not Collected(Participants) | Verum | Sham | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Migraine type(Participants) | Verum | Sham | Total |
|---|---|---|---|
| Migraine with aura | 113 | 111 | 224 |
| Migraine without aura | 146 | 168 | 314 |
| Headache pain severity(Participants) | Verum | Sham | Total |
|---|---|---|---|
| No Pain | 1 | 0 | 1 |
| Mild Pain | 1 | 0 | 1 |
| Moderate pain severity | 155 | 166 | 321 |
| Severe pain severity | 102 | 113 | 215 |
| Most Bothersome Symptom(Participants) | Verum | Sham | Total |
|---|---|---|---|
| Nausea as MBS | 55 | 54 | 109 |
| Vomiting as MBS | 4 | 7 | 11 |
| Sensitivity to light as MBS | 162 | 183 | 345 |
| Sensitivity to sound as MBS | 38 | 35 | 73 |
| Migraine Associated Symptom(occurrences reported by subjects) | Verum | Sham | Total |
|---|---|---|---|
| Photophobia | 247 | 259 | 506 |
| Phonophobia | 207 | 228 | 435 |
| Nausea | 169 | 172 | 341 |
| Vomiting | 23 | 24 | 47 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Jan 2019, 9 months.
Results were first posted in Jul 2019, 5 months after primary completion.
Of 49 industry-sponsored interventional studies with no phase under Migraine Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's 9 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Cefaly Technology