Migraine
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECEFALY
Sponsors
Cefaly Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours. Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited
Exclusion criteria
1. Women: Pregnant, lactating or \<6 months post partum 2. For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period. 3. For patients treated with Botox, no injection within 4 months before start of baseline or during the study. 4. Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache 5. A Beck Depression Inventory score of \>24 at baseline 6. Psychiatric disorders that could have interfered with study participation 7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Frequency of Headache Days | End of baseline period and end of 12 weeks treatment period | 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. |
| Change From Baseline in Acute Medication Intake | End of baseline period and end of 12 weeks treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Monthly Cumulative Headache Hours | End of baseline period and end of 12 weeks treatment period | 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. |
| Change in Frequency of Headache Episodes | End of baseline period and end of 12 weeks treatment period | 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. |
| Change in Frequency of Migraine Days | End of baseline period and end of 12 weeks treatment period | 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. |
| Change in the Average Headache Intensity | End of baseline period and end of 12 weeks treatment period | 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). |
| 50% Responder Rate for Migraine Days | End of the 12 weeks treatment period | 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. |
| Change in Frequency of Moderate/Severe Headache Days | End of baseline period and end of 12 weeks treatment period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
CEFALY | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline Period | Change in prophylactic medication | 3 |
| Baseline Period | Lost to Follow-up | 2 |
| Baseline Period | Screening failure regarding baseline | 7 |
| Baseline Period | Withdrawal by Subject | 3 |
| Treatment Period | Change in prophylactic medication | 1 |
| Treatment Period | Lost to Follow-up | 8 |
| Treatment Period | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Active | — |
|---|---|---|
| Acute medication use (total number) - all categories | 26.33 medications STANDARD_DEVIATION 30.25 | — |
| Age, Continuous | 40.45 years STANDARD_DEVIATION 13.12 | — |
| Average headache intensity | 1.98 units on a scale STANDARD_DEVIATION 0.44 | — |
| Cumulative hours of headache on headache days | 249.64 hours STANDARD_DEVIATION 124.29 | — |
| Number of headache days | 22.55 days STANDARD_DEVIATION 5.38 | — |
| Number of headache episodes | 22.66 episodes STANDARD_DEVIATION 5.35 | — |
| Number of migraine days | 19.02 days STANDARD_DEVIATION 6.36 | — |
| Number of moderate/severe headache days | 16.07 days STANDARD_DEVIATION 7.65 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 49 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 26 / 58 |
| serious Total, serious adverse events | 1 / 58 |
Outcome results
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.
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change From Baseline in Acute Medication Intake | -8.11 medications per 28-days | Standard Deviation 18.74 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change From Baseline in Frequency of Headache Days | -3.12 days per 28-days | Standard Deviation 5.7 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: End of the 12 weeks treatment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | 50% Responder Rate for Migraine Days | 11 Participants |
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.
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Frequency of Headache Episodes | -3.12 episodes per 28-days | Standard Deviation 5.77 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Frequency of Migraine Days | -3.35 days per 28-days | Standard Deviation 6.2 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Frequency of Moderate/Severe Headache Days | -3.10 days per 28-days | Standard Deviation 5.98 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Monthly Cumulative Headache Hours | -27.22 hours per 28-days | Standard Deviation 80.46 |
p-value: 0.012Wilcoxon (Mann-Whitney)
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).
Time frame: End of baseline period and end of 12 weeks treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in the Average Headache Intensity | -0.12 units on a scale | Standard Deviation 0.37 |
p-value: 0.03Wilcoxon (Mann-Whitney)