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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465904
Recruitment Status : Completed
First Posted : March 14, 2018
Results First Posted : July 1, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE March 14, 2018
Results First Submitted Date  ICMJE June 5, 2019
Results First Posted Date  ICMJE July 1, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE April 10, 2018
Actual Primary Completion Date January 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • 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.
  • 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.
  • Use of rescue medication between 2 and 24 hours [ Time Frame: 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 [ 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.
  • Sustained pain relief at 24 hours [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Official Title  ICMJE A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Verum
    2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack
    Intervention: Device: Verum Cefaly® Abortive Program device
  • 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
    Intervention: Device: Sham Cefaly® Abortive Program device
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019)		 601
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)		 600
Actual Study Completion Date  ICMJE January 11, 2019
Actual Primary Completion Date January 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465904
Other Study ID Numbers  ICMJE 51401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cefaly Technology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cefaly Technology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deena Kuruvilla, M.D. Yale School of Medicine
PRS Account Cefaly Technology
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP