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The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active device | Experimental | 60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device |
|
| Sham device | Sham Comparator | 60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEFALY Active | Device | Active external trigeminal nerve stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score 1-hour | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Medication 2 Hours | Number of patients not having required rescue medication at 2 hours | 2 hours |
| Pain Score 2 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Chou, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| Rowe Neurology Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41981402 | Derived | Ye Y, Xie X, Huang H, Zhang H, Yu Y, Qu W. Efficacy and safety of transcutaneous supraorbital nerve stimulation versus topiramate for migraine prevention: a non-inferiority randomized trial. J Headache Pain. 2026 Apr 14;27(1):143. doi: 10.1186/s10194-026-02367-2. | |
| 30449151 | Derived | Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019 Jan;39(1):3-14. doi: 10.1177/0333102418811573. Epub 2018 Nov 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Device | 60 minutes of active external trigeminal nerve stimulation with a CEFALY device CEFALY Active: Active external trigeminal nerve stimulation |
| FG001 | Sham Device | 60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device CEFALY Placebo: Placebo external trigeminal nerve stimulation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Device | 60 minutes of active external trigeminal nerve stimulation with a CEFALY device CEFALY Active: Active external trigeminal nerve stimulation |
| BG001 | Sham Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score 1-hour | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline | Posted | Mean | Standard Deviation | percent change | 1 hour |
|
24 hours following the beginning of the treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Device | 60 minutes of active external trigeminal nerve stimulation with a CEFALY device CEFALY Active: Active external trigeminal nerve stimulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Nervous system disorders | Non-systematic Assessment | After ending the session early (7 minutes), the patient reported nausea that was not present prior to treatment; the nausea resolved without intervention after 20 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Department director | CEFALY Technology | +32 4 367 67 22 | info@cefaly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2016 | Feb 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| CEFALY Placebo |
| Device |
Placebo external trigeminal nerve stimulation |
|
| 2 hours |
| Rescue Medication 24 Hours | Number of patients not having required rescue medication within 24 hours | 24 hours |
| Pain Score 24 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used) | 24 hours |
| Lenexa |
| Kansas |
| 66214-9836 |
| United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Migraine type | Count of Participants | Participants |
|
| Migraine duration (hours) | Median | Inter-Quartile Range | hours |
|
| Use of acute medication before enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Pain Score 1-hour | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline | Posted | Mean | Standard Deviation | units on a scale | 1 hour |
|
|
|
|
| Secondary | Rescue Medication 2 Hours | Number of patients not having required rescue medication at 2 hours | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Secondary | Pain Score 2 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used) | Posted | Mean | Standard Deviation | percent change | 2 hours |
|
|
|
|
| Secondary | Rescue Medication 24 Hours | Number of patients not having required rescue medication within 24 hours | Posted | Count of Participants | Participants | 24 hours |
|
|
|
|
| Secondary | Pain Score 24 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used) | Posted | Mean | Standard Deviation | percent change | 24 hours |
|
|
|
|
| Secondary | Pain Score 2 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used) | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
|
|
|
| Secondary | Pain Score 24 Hours | Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used) | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 1 |
| 52 |
| EG001 | Sham Device | 60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device CEFALY Placebo: Placebo external trigeminal nerve stimulation | 0 | 54 | 0 | 54 | 0 | 54 |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 60 days from the time submitted to the sponsor for review. Sponsor may request:
Sponsor cannot require editorial changes. Sponsor's consent is required for results communication before trial completion
| D009422 | Nervous System Diseases |
| Patients for whom med data was not available |
|
| Patients for whom med data was not available |
|