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The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.
The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Daily trigeminal nerve stimulation session of 20 minutes with CEFALY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEFALY | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Frequency of Headache Days | Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period |
| Change From Baseline in Acute Medication Intake | Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Migraine Days | Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period |
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Inclusion Criteria:
Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marius Birlea, MD | Department of Neurology, University of Colorado Anschutz Medical Campus | Principal Investigator |
| Pierre Rigaux | Cefaly Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus - Department of Neurology | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period |
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| ||||||||||||||||||||||||
| Treatment Period |
|
Participants who were included in the treatment period
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY |
| 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 | Change From Baseline in Frequency of Headache Days | Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Mean | Standard Deviation | days per 28-days | End of baseline period and end of 12 weeks treatment period |
|
|
The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
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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 | Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening myasthenia gravis and worsening migraine headache | Nervous system disorders | Non-systematic Assessment | This SAE occurred the same day as the patient entered the treatment period but before using the Cefaly® device. Consequently, this SAE was considered not related to the use of the Cefaly® device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold, sinus infection, respiratory virus, sore throat, fever, flu-like symptoms | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Department director | CEFALY Technology | +3243676722 | 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 | Aug 12, 2015 | Aug 21, 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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| Change in Frequency of Moderate/Severe Headache Days | Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period |
| Change in Monthly Cumulative Headache Hours | Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period |
| Change in Frequency of Headache Episodes | Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of baseline period and end of 12 weeks treatment period |
| 50% Responder Rate for Migraine Days | Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment. | End of the 12 weeks treatment period |
| Change in the Average Headache Intensity | Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain). | End of baseline period and end of 12 weeks treatment period |
| Screening failure regarding baseline |
|
|
| 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 |
|
| Number of headache episodes | Mean | Standard Deviation | episodes |
|
| Number of headache days | Mean | Standard Deviation | days |
|
| Number of moderate/severe headache days | Mean | Standard Deviation | days |
|
| Number of migraine days | Mean | Standard Deviation | days |
|
| Cumulative hours of headache on headache days | Mean | Standard Deviation | hours |
|
| Average headache intensity | Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain) | Mean | Standard Deviation | units on a scale |
|
| Acute medication use (total number) - all categories | Mean | Standard Deviation | medications |
|
|
|
| Primary | Change From Baseline in Acute Medication Intake | Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Mean | Standard Deviation | medications per 28-days | End of baseline period and end of 12 weeks treatment period |
|
|
|
|
| Secondary | Change in Frequency of Migraine Days | Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Mean | Standard Deviation | days per 28-days | End of baseline period and end of 12 weeks treatment period |
|
|
|
|
| Secondary | Change in Frequency of Moderate/Severe Headache Days | Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Mean | Standard Deviation | days per 28-days | End of baseline period and end of 12 weeks treatment period |
|
|
|
|
| Secondary | Change in Monthly Cumulative Headache Hours | Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Mean | Standard Deviation | hours per 28-days | End of baseline period and end of 12 weeks treatment period |
|
|
|
|
| Secondary | Change in Frequency of Headache Episodes | Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Mean | Standard Deviation | episodes per 28-days | End of baseline period and end of 12 weeks treatment period |
|
|
|
|
| Secondary | 50% Responder Rate for Migraine Days | Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment. | Posted | Count of Participants | Participants | End of the 12 weeks treatment period |
|
|
|
| Secondary | Change in the Average Headache Intensity | Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain). | Posted | Mean | Standard Deviation | units on a scale | End of baseline period and end of 12 weeks treatment period |
|
|
|
|
| 0 |
| 58 |
| 1 |
| 58 |
| 26 |
| 58 |
|
| Gastroenteritis, stomach flu, norovirus | Infections and infestations | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
|
| Migraine, worsening headaches | Nervous system disorders | Non-systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgical interventions | Surgical and medical procedures | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin irritation (Dermatitis forehead) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Only these 2 AEs were related to the use of the Cefaly® device. |
|
| Burning sensation on forehead | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Only these 2 AEs were related to the use of the Cefaly® device. |
|
| Worsening vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Rash both arms and neck | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Kidney stone pain | Renal and urinary disorders | Non-systematic Assessment |
|
| Diagnosis of fibromyalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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:
| D009422 | Nervous System Diseases |