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this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)
The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Relivion Active device |
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| Sham | Sham Comparator | Relivion Sham device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relivion active | Device | 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation | the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used) | 2 hours from treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation | The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Safety of the study device following study treatment: Number and Rate of participates with Adverse events related or unrelated to the study device | From Enrollment (randomization) through study exit i.e. 70 days |
| The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| stewart J. Tepper, Dr. | Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consortium, an AMR company | Tempe | Arizona | 85283 | United States | ||
| Hartford HealthCare Headache Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35748757 | Derived | Tepper SJ, Grosberg B, Daniel O, Kuruvilla DE, Vainstein G, Deutsch L, Sharon R. Migraine treatment with external concurrent occipital and trigeminal neurostimulation-A randomized controlled trial. Headache. 2022 Sep;62(8):989-1001. doi: 10.1111/head.14350. Epub 2022 Jun 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Relivion Active device Relivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation |
| FG001 | Sham | Relivion Sham device Relivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2019 | Apr 14, 2022 |
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| Relivion Sham | Device | 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation |
|
| 2 hours from treatment initiation |
| Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation | The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack | 1 hour from treatment initiation |
| Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation | The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack | 2 hours from treatment initiation |
as per the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" June 2020 FDA Guidance, which states that a modifications to the definition and ascertainment of trial endpoints may be warranted to address the impact of COVID-19. A potential modification for a binary endpoint that is based on a continuous or ordinal measurement is by using the continuous or ordinal measurement as the endpoint. therefore, an additional analysis to the study end points , the migraine headache pain level was transformed into a numerical score (pseudo-continuous): "No pain"=0, "Mild"=1, "Moderate"=2, "Severe"=3. If rescue medication was used, the score after the rescue intake post-treatment are set to the baseline value. The change from baseline is compared between the study arms with an analysis of covariance model adjusted for site and baseline pain level. |
| baseline to 1-hour post treatment |
| Hartford |
| Connecticut |
| 06107 |
| United States |
| Yale School of Medicine | New Haven | Connecticut | 06519 | United States |
| Regeneris Medical | North Attleboro | Massachusetts | 02760 | United States |
| Clinical Research Consortium, an AMR company | Las Vegas | Nevada | 89119 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Barzilai MC | Ashkelon | Israel |
| Hillel Yaffe Medical Center | Hadera | Israel |
| Sharei Zedek MC | Jerusalem | Israel |
| Macabi healtcenter services | Kfar Saba | Israel |
| Laniado MC | Netanya | Israel |
| Macabi healtcenter services | Raanana | Israel |
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| The ITT Analysis Set | The Intent to Treat (ITT) analysis set which includes all randomized subjects who were treated with the device after May 31, 2019 (including self-practice). Per ITT principles, all subjects were analyzed as randomized. |
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| The mITT Analysis Set | The mITT analysis set which includes all subjects from the ITT analysis set who treat at least one eligible attack (excluding the "self-practice test") analyzed as treated. |
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| COMPLETED | from FA set |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Relivion Active device Relivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation |
| BG001 | Sham | Relivion Sham device Relivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation | the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used) | mITT present the number and percentage of subjects with pain relief (reduction in pain level) 2 hours post-treatment, from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated episode. If a subject had used rescue medication up to the assessment time point, he/she was considered as not reaching the endpoint. mITT set included 50 patients in the Active arm and 59 patients in the sham arm | Posted | Count of Participants | Participants | 2 hours from treatment initiation |
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| Secondary | Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation | The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia | mITT population analysis. mITT set included 50 patients in the Active arm from which 36 reported MBS and 59 patients in the sham arm from which 45 reported MBS | Posted | Count of Participants | Participants | 2 hours from treatment initiation |
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| Secondary | Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation | The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack | mITT population analysis. mITT set included 50 patients in the Active arm and 59 patients in the sham arm | Posted | Count of Participants | Participants | 1 hour from treatment initiation |
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| Secondary | Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation | The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack | mITT population anaylsis. mITT set included 50 patients in the Active arm and 59 patients in the sham arm | Posted | Count of Participants | Participants | 2 hours from treatment initiation |
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| Other Pre-specified | Number of Participants With Adverse Events | Safety of the study device following study treatment: Number and Rate of participates with Adverse events related or unrelated to the study device | ITT population analysis | Posted | Count of Participants | Participants | From Enrollment (randomization) through study exit i.e. 70 days |
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| Other Pre-specified | The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment | as per the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" June 2020 FDA Guidance, which states that a modifications to the definition and ascertainment of trial endpoints may be warranted to address the impact of COVID-19. A potential modification for a binary endpoint that is based on a continuous or ordinal measurement is by using the continuous or ordinal measurement as the endpoint. therefore, an additional analysis to the study end points , the migraine headache pain level was transformed into a numerical score (pseudo-continuous): "No pain"=0, "Mild"=1, "Moderate"=2, "Severe"=3. If rescue medication was used, the score after the rescue intake post-treatment are set to the baseline value. The change from baseline is compared between the study arms with an analysis of covariance model adjusted for site and baseline pain level. | mITT set included 50 patients in the Active arm and 59 patients in the sham arm | Posted | Mean | 95% Confidence Interval | units on a scale | baseline to 1-hour post treatment |
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Adverse events data were collected per study participant from Enrollment (randomization) through study exit. ie 70 days
Adverse events related or unrelated to the study device and/or procedure were collected per study participant from Enrollment (randomization) through study exit. The ITT data analysis set served as the principal data analysis set for the safety analyses.
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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 | Relivion Active device Relivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation | 0 | 67 | 0 | 67 | 8 | 67 |
| EG001 | Sham | Relivion Sham device Relivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation | 0 | 64 | 0 | 64 | 2 | 64 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Unpleasant sensation during treatment | Nervous system disorders | Non-systematic Assessment |
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| Scalp numbness sensation | Nervous system disorders | Non-systematic Assessment |
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| Pain | Nervous system disorders | Non-systematic Assessment |
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| Skin redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Tingling | Nervous system disorders | Non-systematic Assessment |
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| Twitching | Nervous system disorders | Non-systematic Assessment |
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| COVID | Infections and infestations | Non-systematic Assessment |
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| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| inner ear scratch | Ear and labyrinth disorders | Non-systematic Assessment |
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| lip numbness | General disorders | Non-systematic Assessment |
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| Pressure/discomfort of head | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michal Kedar-Datel | Neurolief Ltd. | +972-52-6659806 | michal.kedar-datel@neurolief.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2020 | Apr 14, 2022 | SAP_001.pdf |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Israel |
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