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

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ClinicalTrials.gov Identifier: NCT03465904
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

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.

Condition or disease Intervention/treatment Phase
Migraine Device: Verum Cefaly® Abortive Program device Device: Sham Cefaly® Abortive Program device Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Verum
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
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.

Sham Comparator: Sham
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
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 Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Pain Relief 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 a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.

  2. Percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours [ Time Frame: 2 hours ]
    The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.

  3. Use of rescue medication between 2 and 24 hours [ Time Frame: 2-24 hours ]
    The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.

  4. Sustained pain freedom at 24 hours [ Time Frame: 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.

  5. Sustained pain relief at 24 hours [ Time Frame: 2-24 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ICHD-III 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 AE 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465904


Locations
United States, Arizona
Clinical Research Consortium
Tempe, Arizona, United States, 85283
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Florida
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Meridian Clinical Research (Savannah Neurology)
Savannah, Georgia, United States, 31406
United States, Maryland
Meridian Clinical Research (Rockville Neurology)
Rockville, Maryland, United States, 20854
United States, Nevada
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, Ohio
Rapid Medical Research Inc.
Cleveland, Ohio, United States, 44122
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Cefaly Technology

Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT03465904     History of Changes
Other Study ID Numbers: 51401
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases