N/A
Completed N=59
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Source: ClinicalTrials.gov NCT03217968 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Pain Freedom (PF) at 2 Hours — 17 Participants
Summary
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Freedom (PF) at 2 Hours |
17 | — |
| PRIMARY Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours |
29 | — |
| SECONDARY Pain Relief (PR) at 2 Hours |
34 | — |
| SECONDARY Migraine-associated Symptoms Freedom at 2 Hours |
22 | — |
| SECONDARY Use of Rescue Medication Between 2 and 24 Hours |
24 | — |
| SECONDARY Sustained Pain Freedom at 24 Hours |
12 | — |
Eligibility Criteria
Inclusion Criteria
- Age from 18 to 65 years 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 the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
- Migraine onset before the age of 50 years
- 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 (AE) collecting 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 included Medication Overuse Headache
- Patients abusing opioids or user of recreational or illicit drugs or has 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 within 30 days of screening visit (Visit 1)
- Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site
Data sourced from ClinicalTrials.gov (NCT03217968). 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.