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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verum Cefaly® Abortive Program device
Sham Cefaly® Abortive Program device
Sponsored by
Cefaly Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Consortium
  • Pharmacology Research Institute
  • Yale University
  • Palm Beach Research Center
  • Meridian Clinical Research (Savannah Neurology)
  • Meridian Clinical Research (Rockville Neurology)
  • Clinical Research Consortium
  • Rochester Clinical Research
  • Rapid Medical Research Inc.
  • Coastal Carolina Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verum

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Pain Relief at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
Use of Rescue Medication Between 2 and 24 Hours
The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
Sustained Pain Freedom at 24 Hours
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Sustained Pain Relief at 24 Hours
The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.

Full Information

First Posted
March 8, 2018
Last Updated
July 2, 2019
Sponsor
Cefaly Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03465904
Brief Title
A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Acronym
TEAM
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cefaly Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
Intervention Type
Device
Intervention Name(s)
Verum Cefaly® Abortive Program device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Cefaly® Abortive Program device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Freedom at 2 Hours
Description
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.
Time Frame
2 hours
Title
Most Bothersome Migraine-associated Symptom Freedom at 2 Hours
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain Relief at 2 Hours
Description
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Time Frame
2 hours
Title
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours
Description
The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.
Time Frame
2 hours
Title
Use of Rescue Medication Between 2 and 24 Hours
Description
The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.
Time Frame
2-24 hours
Title
Sustained Pain Freedom at 24 Hours
Description
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Time Frame
24 hours
Title
Sustained Pain Relief at 24 Hours
Description
The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Time Frame
2-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deena Kuruvilla, M.D.
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Consortium
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Meridian Clinical Research (Savannah Neurology)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Meridian Clinical Research (Rockville Neurology)
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Rapid Medical Research Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35332216
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.
Results Reference
derived

Learn more about this trial

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

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