A Phase III Trial of e-TNS for the Acute Treatment of Migraine

Not Applicable

Completed

Interventions: Device: Sham Cefaly® Abortive Program device
Device: Verum Cefaly® Abortive Program device

Brief Summary: The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.

Detailed Description: The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Recruitment & Eligibility

Inclusion Criteria

Age from 18 to 65 on the day of signing the informed consent form
≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
Migraine onset before the age of 50
Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events reporting form)

Exclusion Criteria

Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
Patient has more than 15 headache days per month
Patient having received supraorbital nerve blocks in the prior 4 months
Patient having received Botox treatment in the prior 4 months
Modification of a migraine prophylaxis treatment in the previous 3 months
Diagnosis of other primary headache disorders, except rare (< 4) tension-type headaches per month
Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH)
Patient abusing opioids or user of recreational or illicit drugs or having had a recent history (within the last year) of drug or alcohol abuse or dependence
Implanted metallic or electronic device in the head
Cardiac pacemaker or implanted or wearable defibrillator
Patient having had a previous experience with the Cefaly® device
Migraine Aura without headache
Patient is currently participating or has participated in a study with an investigational compound or device in the last 30 days before the screening visit (Visit 1)
Patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site

Arm && Interventions

Group	Intervention	Description
Sham	Sham Cefaly® Abortive Program device	2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Verum	Verum Cefaly® Abortive Program device	2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack

Primary Outcome Measures

Name	Time	Method
Pain Freedom at 2 Hours	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.
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours	2 hours	The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
Pain Relief at 2 Hours	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.
Sustained Pain Freedom at 24 Hours	24 hours	The 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.
Use of Rescue Medication Between 2 and 24 Hours	2-24 hours	The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
Sustained Pain Relief at 24 Hours	2-24 hours	The 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.

Locations (9): Meridian Clinical Research (Savannah Neurology)
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Savannah, Georgia, United States
Palm Beach Research Center
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West Palm Beach, Florida, United States
Pharmacology Research Institute
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Encino, California, United States
Rapid Medical Research Inc.
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Cleveland, Ohio, United States
Rochester Clinical Research
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Rochester, New York, United States
Clinical Research Consortium
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Las Vegas, Nevada, United States
Meridian Clinical Research (Rockville Neurology)
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Rockville, Maryland, United States
Yale University
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New Haven, Connecticut, United States
Coastal Carolina Research Center
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Mount Pleasant, South Carolina, United States