N/A
Completed N=607
A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Source: ClinicalTrials.gov NCT03465904 ↗Enrolled (actual)
607
Serious AEs
0.2%
Results posted
Jul 2019
Primary outcomePrimary: Pain Freedom at 2 Hours — 66; 51 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Freedom at 2 Hours |
66; 51 | — |
| PRIMARY Most Bothersome Migraine-associated Symptom Freedom at 2 Hours |
146; 118 | — |
| SECONDARY Pain Relief at 2 Hours |
180; 154 | — |
| SECONDARY Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours |
110; 95 | — |
| SECONDARY Use of Rescue Medication Between 2 and 24 Hours |
82; 105 | — |
| SECONDARY Sustained Pain Freedom at 24 Hours |
59; 44 | — |
| SECONDARY Sustained Pain Relief at 24 Hours |
119; 96 | <0.05 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03465904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.