Trial Outcomes & Findings for Abortive Treatment of Migraine With the Cefaly® Abortive Program Device (NCT NCT03217968)

NCT ID: NCT03217968

Last Updated: 2018-08-07

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: 59 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2018-08-07

Participant Flow

Participant milestones

Measure	Active 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Overall Study STARTED	59
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Active 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Age, Continuous	46.85 years STANDARD_DEVIATION 10.2 • n=48 Participants
Sex: Female, Male Female	43 Participants n=48 Participants
Sex: Female, Male Male	5 Participants n=48 Participants
Migraine type Migraine with aura	15 Participants n=48 Participants
Migraine type Migraine without aura	33 Participants n=48 Participants
Migraine intensity Moderate intensity at baseline	33 Participants n=48 Participants
Migraine intensity Severe intensity at baseline	15 Participants n=48 Participants
Most bothersome syndrome Nausea	11 Participants n=48 Participants
Most bothersome syndrome Vomiting	1 Participants n=48 Participants
Most bothersome syndrome Sensitivity to light	27 Participants n=48 Participants
Most bothersome syndrome Sensitivity to sound	9 Participants n=48 Participants

PRIMARY outcome

Timeframe: 2 hours

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.

Outcome measures

Measure	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Pain Freedom (PF) at 2 Hours	17 Participants

PRIMARY outcome

Timeframe: 2 hours

The 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	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours	29 Participants

SECONDARY outcome

Timeframe: 2 hours

The 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	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Pain Relief (PR) at 2 Hours	34 Participants

SECONDARY outcome

Timeframe: 2 hours

The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.

Outcome measures

Measure	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Migraine-associated Symptoms Freedom at 2 Hours	22 Participants

SECONDARY outcome

Timeframe: Between 2 and 24 hours

The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.

Outcome measures

Measure	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Use of Rescue Medication Between 2 and 24 Hours	24 Participants

SECONDARY outcome

Timeframe: 24 hours

The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.

Outcome measures

Measure	Active n=48 Participants 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Sustained Pain Freedom at 24 Hours	12 Participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active n=59 participants at risk 120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack 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).
Skin and subcutaneous tissue disorders Burning sensation on the forehead	11.9% 7/59 • Number of events 7 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Dizziness	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment
Skin and subcutaneous tissue disorders itching/tingling/stinging/numbness sensation on forehead	6.8% 4/59 • Number of events 4 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Nausea	3.4% 2/59 • Number of events 2 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Vomiting	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Pain in the jaw	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Discomfort in teeth	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Drowsiness	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment
Blood and lymphatic system disorders Cold feet	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment
Nervous system disorders Pain in eyes	1.7% 1/59 • Number of events 1 • The data was collected during the 24 hours following the start of the treatment

Additional Information

Clinical Trial Department director

CEFALY Technology

Phone: +3243676722

Email: info@cefaly.com

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
• Publication restrictions are in place

Restriction type: OTHER