Status:
COMPLETED
A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Lead Sponsor:
Cefaly Technology
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
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-blin...
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 us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2019
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT03465904
Start Date
April 10 2018
End Date
January 11 2019
Last Update
December 11 2024
Active Locations (10)
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1
Clinical Research Consortium
Tempe, Arizona, United States, 85283
2
Pharmacology Research Institute
Encino, California, United States, 91316
3
Yale University
New Haven, Connecticut, United States, 06519
4
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409