A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cefaly Technology
- Enrollment
- 607
- Locations
- 19
- Primary Endpoint
- Pain Freedom at 2 Hours
Study Overview
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-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.
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 used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Verum
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Intervention: Verum Cefaly® Abortive Program device (Device)
Sham
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Intervention: Sham Cefaly® Abortive Program device (Device)
Outcomes
Primary Outcomes
Pain Freedom at 2 Hours
Time Frame: 2 hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
Time Frame: 2 hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Secondary Outcomes
- Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours(2 hours)
- Pain Relief at 2 Hours(2 hours)
- Sustained Pain Freedom at 24 Hours(24 hours)
- Use of Rescue Medication Between 2 and 24 Hours(2-24 hours)
- Sustained Pain Relief at 24 Hours(2-24 hours)