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

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT03465904

Run by

Cefaly Technology

People needed

607

Starts

2018-04-10

Expected to finish

2019-01-11

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.