A Phase III Trial of e-TNS for the Acute Treatment of Migraine

NCT03465904 | Completed Results FDA Device

• 1 other identifier: 51401
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 10

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Pain Freedom at 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.

  2 hours

• Most Bothersome Migraine-associated Symptom Freedom at 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.

  2 hours

Secondary Outcomes (5)

• Pain Relief at 2 Hours

  2 hours

• Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours

  2 hours

• Use of Rescue Medication Between 2 and 24 Hours

  2-24 hours

• Sustained Pain Freedom at 24 Hours

  24 hours

• Sustained Pain Relief at 24 Hours

  2-24 hours

Study Arms (2)

Verum

EXPERIMENTAL

2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack

Device: Verum Cefaly® Abortive Program device

Sham

SHAM COMPARATOR

2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack

Device: Sham Cefaly® Abortive Program device

Interventions

Verum Cefaly® Abortive Program device DEVICE

The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.

Verum

Sham Cefaly® Abortive Program device DEVICE

The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cefaly Technology: lead

Study Sites (10)

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Meridian Clinical Research (Savannah Neurology)

Savannah, Georgia, 31406, United States

Location

Meridian Clinical Research (Rockville Neurology)

Rockville, Maryland, 20854, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Rapid Medical Research Inc.

Cleveland, Ohio, 44122, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Related Publications (1)

• 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.

  PMID: 35332216 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Trials Department director
• Organization: CEFALY Technology

ClinicalTrial@cefaly.com

+32 4 367 67 22

Study Officials

• Deena Kuruvilla, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: April 10, 2018
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: December 11, 2024
• Results First Posted: July 1, 2019

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)