Trial Outcomes & Findings for A Phase III Trial of e-TNS for the Acute Treatment of Migraine (NCT NCT03465904)
NCT ID: NCT03465904
Last Updated: 2024-12-11
Results Overview
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
607 participants
Primary outcome timeframe
2 hours
Results posted on
2024-12-11
Participant Flow
Between April 10, 2018 and January 11, 2019, 626 subjects were screened for eligibility, and 607 were enrolled across ten centers in the United States.
Participant milestones
| Measure |
Verum
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
299
|
308
|
|
Overall Study
COMPLETED
|
259
|
279
|
|
Overall Study
NOT COMPLETED
|
40
|
29
|
Reasons for withdrawal
| Measure |
Verum
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
|
Overall Study
Protocol Violation
|
20
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
Total
n=538 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.22 years
STANDARD_DEVIATION 11.62 • n=259 Participants
|
42.0 years
STANDARD_DEVIATION 12.30 • n=279 Participants
|
41.14 years
STANDARD_DEVIATION 12.00 • n=538 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=259 Participants
|
229 Participants
n=279 Participants
|
443 Participants
n=538 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=259 Participants
|
50 Participants
n=279 Participants
|
95 Participants
n=538 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Migraine type
Migraine with aura
|
113 Participants
n=259 Participants
|
111 Participants
n=279 Participants
|
224 Participants
n=538 Participants
|
|
Migraine type
Migraine without aura
|
146 Participants
n=259 Participants
|
168 Participants
n=279 Participants
|
314 Participants
n=538 Participants
|
|
Headache pain severity
No Pain
|
1 Participants
n=259 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=538 Participants
|
|
Headache pain severity
Mild Pain
|
1 Participants
n=259 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=538 Participants
|
|
Headache pain severity
Moderate pain severity
|
155 Participants
n=259 Participants
|
166 Participants
n=279 Participants
|
321 Participants
n=538 Participants
|
|
Headache pain severity
Severe pain severity
|
102 Participants
n=259 Participants
|
113 Participants
n=279 Participants
|
215 Participants
n=538 Participants
|
|
Most Bothersome Symptom
Nausea as MBS
|
55 Participants
n=259 Participants
|
54 Participants
n=279 Participants
|
109 Participants
n=538 Participants
|
|
Most Bothersome Symptom
Vomiting as MBS
|
4 Participants
n=259 Participants
|
7 Participants
n=279 Participants
|
11 Participants
n=538 Participants
|
|
Most Bothersome Symptom
Sensitivity to light as MBS
|
162 Participants
n=259 Participants
|
183 Participants
n=279 Participants
|
345 Participants
n=538 Participants
|
|
Most Bothersome Symptom
Sensitivity to sound as MBS
|
38 Participants
n=259 Participants
|
35 Participants
n=279 Participants
|
73 Participants
n=538 Participants
|
|
Migraine Associated Symptom
Photophobia
|
247 occurrences reported by subjects
n=259 Participants
|
259 occurrences reported by subjects
n=279 Participants
|
506 occurrences reported by subjects
n=538 Participants
|
|
Migraine Associated Symptom
Phonophobia
|
207 occurrences reported by subjects
n=259 Participants
|
228 occurrences reported by subjects
n=279 Participants
|
435 occurrences reported by subjects
n=538 Participants
|
|
Migraine Associated Symptom
Nausea
|
169 occurrences reported by subjects
n=259 Participants
|
172 occurrences reported by subjects
n=279 Participants
|
341 occurrences reported by subjects
n=538 Participants
|
|
Migraine Associated Symptom
Vomiting
|
23 occurrences reported by subjects
n=259 Participants
|
24 occurrences reported by subjects
n=279 Participants
|
47 occurrences reported by subjects
n=538 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Outcome measures
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Pain Freedom at 2 Hours
|
66 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Outcome measures
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
|
146 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: 2 hoursThe percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Outcome measures
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Pain Relief at 2 Hours
|
180 Participants
|
154 Participants
|
SECONDARY outcome
Timeframe: 2 hoursThe percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
Outcome measures
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
|
110 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: 2-24 hoursThe percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
Outcome measures
| Measure |
Verum
n=209 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=237 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Use of Rescue Medication Between 2 and 24 Hours
|
82 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: 24 hoursThe percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Outcome measures
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Sustained Pain Freedom at 24 Hours
|
59 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 2-24 hoursThe percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Outcome measures
| Measure |
Verum
n=259 Participants
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 Participants
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Sustained Pain Relief at 24 Hours
|
119 Participants
|
96 Participants
|
Adverse Events
Verum
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Sham
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verum
n=259 participants at risk；n=298 participants at risk
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 participants at risk；n=303 participants at risk
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Surgical and medical procedures
Appendicitis leading to appendectomy
|
0.00%
0/298 • The data was collected during the 24 hours following the beginning of the treatment
|
0.33%
1/303 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
Other adverse events
| Measure |
Verum
n=259 participants at risk；n=298 participants at risk
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
|
Sham
n=279 participants at risk；n=303 participants at risk
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Sham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
|
|---|---|---|
|
Nervous system disorders
Forehead paresthesias, discomfort, or burning
|
3.5%
9/259 • Number of events 9 • The data was collected during the 24 hours following the beginning of the treatment
|
0.36%
1/279 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Nausea / Vomiting
|
1.5%
4/259 • Number of events 4 • The data was collected during the 24 hours following the beginning of the treatment
|
0.00%
0/279 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Dizziness
|
0.39%
1/259 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
0.72%
2/279 • Number of events 2 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Neck Stiffness / Muscle tension
|
0.39%
1/259 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
0.72%
2/279 • Number of events 2 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Worsened Headache
|
0.77%
2/259 • Number of events 2 • The data was collected during the 24 hours following the beginning of the treatment
|
0.00%
0/279 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Skin and subcutaneous tissue disorders
Orodynia - tooth or jaw pain
|
0.39%
1/259 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
0.36%
1/279 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Restlessness
|
0.39%
1/259 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
0.36%
1/279 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Ear and labyrinth disorders
Abdominal Discomfort or Cramping
|
0.00%
0/259 • The data was collected during the 24 hours following the beginning of the treatment
|
0.72%
2/279 • Number of events 2 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Dry Mouth
|
0.39%
1/259 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
0.00%
0/279 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Excessive Sweating
|
0.77%
2/259 • Number of events 2 • The data was collected during the 24 hours following the beginning of the treatment
|
0.00%
0/279 • The data was collected during the 24 hours following the beginning of the treatment
|
|
Nervous system disorders
Sleepiness / Sedation
|
0.39%
1/259 • Number of events 1 • The data was collected during the 24 hours following the beginning of the treatment
|
0.00%
0/279 • The data was collected during the 24 hours following the beginning of the treatment
|
Additional Information
Clinical Trials Department director
CEFALY Technology
Phone: +32 4 367 67 22
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted to the sponsor for review. Sponsor may request: * deletion of any trade secret, proprietary, or confidential information of Sponsor * an additional 90 days to take measures to preserve its Intellectual Property rights Sponsor's written consent is required for results communication before trial completion.
- Publication restrictions are in place
Restriction type: OTHER