An interventional study of CEFALY Active and CEFALY Placebo in Migraine, sponsored by Cefaly Technology. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Cefaly Technology · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 106 is above 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.
Exclusion Criteria:
60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
Device: CEFALY Active
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
Device: CEFALY Placebo
Active external trigeminal nerve stimulation
Placebo external trigeminal nerve stimulation
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
Time frame: 1 hour
Rescue Medication 2 Hours
Number of patients not having required rescue medication at 2 hours
Time frame: 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)
Time frame: 2 hours
Rescue Medication 24 Hours
Number of patients not having required rescue medication within 24 hours
Time frame: 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)
Time frame: 24 hours
| Milestone | Active Device | Sham Device |
|---|---|---|
| Started | 52 | 54 |
| Completed | 47 | 52 |
| Not completed | 5 | 2 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Failed the nociceptive test | 2 | 1 |
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
| percent change | Active Device | Sham Device |
|---|---|---|
| Pain Score 1-hour | -59 ± 35 | -30 ± 31 |
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
| units on a scale | Active Device | Sham Device |
|---|---|---|
| Pain Score 1-hour | -3.46 ± 2.32 | -1.78 ± 1.89 |
Number of patients not having required rescue medication at 2 hours
| Participants | Active Device | Sham Device |
|---|---|---|
| Patients having used rescue medication at 2 hours | 3 | 2 |
| Patients not having used rescue medication at 2 h | 44 | 50 |
| Patients for whom med data was not available | 5 | 2 |
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)
| percent change | Active Device | Sham Device |
|---|---|---|
| Pain Score 2 Hours | -50 ± 36 | -32 ± 37 |
Number of patients not having required rescue medication within 24 hours
| Participants | Active Device | Sham Device |
|---|---|---|
| Patients having used rescue medication within 24 h | 18 | 21 |
| Patients not having used rescue med within 24h | 27 | 30 |
| Patients for whom med data was not available | 7 | 3 |
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)
| percent change | Active Device | Sham Device |
|---|---|---|
| Pain Score 24 Hours | -57 ± 37 | -40 ± 40 |
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)
| units on a scale | Active Device | Sham Device |
|---|---|---|
| Pain Score 2 Hours | -2.87 ± 2.24 | -1.85 ± 1.96 |
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)
| units on a scale | Active Device | Sham Device |
|---|---|---|
| Pain Score 24 Hours | -3.46 ± 2.65 | -2.38 ± 2.27 |
Collected over 24 hours following the beginning of the treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Device | 0/52 (0%) | 0/52 (0%) | 1/52 (1.9%) |
| Sham Device | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Event | Active Device | Sham Device |
|---|---|---|
| NauseaNervous system disorders | 1/52 | 0/54 |
| Age, Continuous(years) | Active Device | Sham Device | Total |
|---|---|---|---|
| Mean | 39.71 ± 13.62 | 40.09 ± 12.65 | 39.90 ± 13.14 |
| Sex: Female, Male(Participants) | Active Device | Sham Device | Total |
|---|---|---|---|
| Female | 43 | 49 | 92 |
| Male | 9 | 5 | 14 |
| Race and Ethnicity Not Collected(Participants) | Active Device | Sham Device | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Migraine type(Participants) | Active Device | Sham Device | Total |
|---|---|---|---|
| Migraine with aura | 12 | 5 | 17 |
| Migraine without aura | 40 | 49 | 89 |
| Migraine duration (hours)(hours) | Active Device | Sham Device | Total |
|---|---|---|---|
| Median | 7 (4 to 48) | 6 (4.63 to 20.75) | 6 (4 to 24) |
| Use of acute medication before enrollment(Participants) | Active Device | Sham Device | Total |
|---|---|---|---|
| Count of participants | 17 | 14 | 31 |
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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