An interventional study of CEFALY in Migraine, sponsored by Cefaly Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Cefaly Technology · Not applicable, Interventional, and Prevention
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 73 is close to the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Cefaly Technology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited
Exclusion Criteria:
Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
Device: CEFALY
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
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
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
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
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
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
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
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
| Milestone | Active |
|---|---|
| Started | 73 |
| Completed | 58 |
| Not completed | 15 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Change in prophylactic medication | 3 |
| Withdrew: Screening failure regarding baseline | 7 |
| Milestone | Active |
|---|---|
| Started | 58 |
| Completed | 47 |
| Not completed | 11 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Change in prophylactic medication | 1 |
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.
| days per 28-days | Active |
|---|---|
| Change From Baseline in Frequency of Headache Days | -3.12 ± 5.70 |
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.
| medications per 28-days | Active |
|---|---|
| Change From Baseline in Acute Medication Intake | -8.11 ± 18.74 |
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.
| days per 28-days | Active |
|---|---|
| Change in Frequency of Migraine Days | -3.35 ± 6.20 |
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.
| days per 28-days | Active |
|---|---|
| Change in Frequency of Moderate/Severe Headache Days | -3.10 ± 5.98 |
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.
| hours per 28-days | Active |
|---|---|
| Change in Monthly Cumulative Headache Hours | -27.22 ± 80.46 |
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.
| episodes per 28-days | Active |
|---|---|
| Change in Frequency of Headache Episodes | -3.12 ± 5.77 |
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.
| Participants | Active |
|---|---|
| 50% Responder Rate for Migraine Days | 11 |
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).
| units on a scale | Active |
|---|---|
| Change in the Average Headache Intensity | -0.12 ± 0.37 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/58 (0%) | 1/58 (1.7%) | 26/58 (44.8%) |
| Event | Active |
|---|---|
| Worsening myasthenia gravis and worsening migraine headacheNervous system disorders | 1/58 |
| Event | Active |
|---|---|
| Cold, sinus infection, respiratory virus, sore throat, fever, flu-like symptomsInfections and infestations | 15/58 |
| Gastroenteritis, stomach flu, norovirusInfections and infestations | 5/58 |
| Migraine, worsening headachesNervous system disorders | 5/58 |
| HivesSkin and subcutaneous tissue disorders | 2/58 |
| Surgical interventionsSurgical and medical procedures | 2/58 |
| InjuryInjury, poisoning and procedural complications | 2/58 |
| Vaginal infectionInfections and infestations | 1/58 |
| Skin irritation (Dermatitis forehead)Skin and subcutaneous tissue disorders | 1/58 |
| Burning sensation on foreheadSkin and subcutaneous tissue disorders | 1/58 |
| Worsening vertigoNervous system disorders | 1/58 |
Participants who were included in the treatment period
| Age, Continuous(years) | Active |
|---|---|
| Mean | 40.45 ± 13.12 |
| Sex: Female, Male(Participants) | Active |
|---|---|
| Female | 49 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Active |
|---|
| Number of headache episodes(episodes) | Active |
|---|---|
| Mean | 22.66 ± 5.35 |
| Number of headache days(days) | Active |
|---|---|
| Mean | 22.55 ± 5.38 |
| Number of moderate/severe headache days(days) | Active |
|---|---|
| Mean | 16.07 ± 7.65 |
| Number of migraine days(days) | Active |
|---|---|
| Mean | 19.02 ± 6.36 |
| Cumulative hours of headache on headache days(hours) | Active |
|---|---|
| Mean | 249.64 ± 124.29 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Cefaly Technology