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

Cefaly Technology607 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

607

Conditions

Migraine

Interventions

Verum Cefaly® Abortive Program deviceDEVICE

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 Cefaly® Abortive Program deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age from 18 to 65 on the day of signing the informed consent form 2. ≥ 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 3. Migraine onset before the age of 50 4. 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 5. Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent 6. Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events reporting form) Exclusion Criteria: 1. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches 2. Patient has more than 15 headache days per month 3. Patient having received supraorbital nerve blocks in the prior 4 months 4. Patient having received Botox treatment in the prior 4 months 5. Modification of a migraine prophylaxis treatment in the previous 3 months 6. Diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month 7. Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH) 8. 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 9. Implanted metallic or electronic device in the head 10. Cardiac pacemaker or implanted or wearable defibrillator 11. Patient having had a previous experience with the Cefaly® device 12. Migraine Aura without headache 13. 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) 14. 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

Locations (10)

Clinical Research Consortium

Tempe, Arizona, United States

Pharmacology Research Institute

Encino, California, United States

Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Pain Freedom at 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.

Time frame: 2 hours

Most Bothersome Migraine-associated Symptom Freedom at 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.

Time frame: 2 hours

Secondary Outcomes

Pain Relief at 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.

Time frame: 2 hours

Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours

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

Time frame: 2 hours

Use of Rescue Medication Between 2 and 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.

Time frame: 2-24 hours

Sustained Pain Freedom at 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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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