Clinical trial NCT03217968: Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Official title: Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2017-07-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The main objective of this study is to have a pilot assessment 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 pilot data to assess the efficacy 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.

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

Primary outcomes:
measure: Pain Freedom (PF) at 2 Hours
timeFrame: 2 hours
measure: Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours
timeFrame: 2 hours
Secondary outcomes:
measure: Pain Relief (PR) at 2 Hours
timeFrame: 2 hours
measure: Migraine-associated Symptoms Freedom at 2 Hours
timeFrame: 2 hours
measure: Use of Rescue Medication Between 2 and 24 Hours
timeFrame: Between 2 and 24 hours
measure: Sustained Pain Freedom at 24 Hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
Study officials:
affiliation: Rochester Clinical Research
name: Joseph MANN, M.D.
role: PRINCIPAL_INVESTIGATOR
References: