Clinical trial NCT03465904: A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Official title: A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2018-03-14
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 65 on the day of signing the informed consent form
2. ≥ 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
3. Migraine onset before the age of 50
4. 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
5. Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
6. Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events reporting form)

Exclusion Criteria:

1. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
2. Patient has more than 15 headache days per month
3. Patient having received supraorbital nerve blocks in the prior 4 months
4. Patient having received Botox treatment in the prior 4 months
5. Modification of a migraine prophylaxis treatment in the previous 3 months
6. Diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month
7. Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH)
8. 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
9. Implanted metallic or electronic device in the head
10. Cardiac pacemaker or implanted or wearable defibrillator
11. Patient having had a previous experience with the Cefaly® device
12. Migraine Aura without headache
13. 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)
14. 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

Primary outcomes:
measure: Pain Freedom at 2 Hours
timeFrame: 2 hours
measure: Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
timeFrame: 2 hours
Secondary outcomes:
measure: Pain Relief at 2 Hours
timeFrame: 2 hours
measure: Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
timeFrame: 2 hours
measure: Use of Rescue Medication Between 2 and 24 Hours
timeFrame: 2-24 hours
measure: Sustained Pain Freedom at 24 Hours
timeFrame: 24 hours
measure: Sustained Pain Relief at 24 Hours
timeFrame: 2-24 hours
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Research Consortium
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research (Savannah Neurology)
state: Georgia
city: Rockville
country: United States
facility: Meridian Clinical Research (Rockville Neurology)
state: Maryland
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research Inc.
state: Ohio
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
Study officials:
affiliation: Yale University
name: Deena Kuruvilla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.