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

Cefaly Technology

Status

Completed

Conditions

Migraine

Treatments

Device: Verum Cefaly® Abortive Program device

Device: Sham Cefaly® Abortive Program device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03465904

51401

Details and patient eligibility

About

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.

Full 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.

Enrollment

607 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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