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Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

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: NCT03217968
Recruitment Status : Completed
First Posted : July 14, 2017
Results First Posted : June 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

Study Description
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Brief Summary:
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.

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

Detailed Description:
The main objective of this study is to have a pilot assessment 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 pilot data to assess the efficacy 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack
 Device: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Pain Freedom (PF) 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 (MBS) 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 (PR) 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. Migraine-associated Symptoms Freedom at 2 Hours [ Time Frame: 2 hours ]
    The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.

  3. Use of Rescue Medication Between 2 and 24 Hours [ Time Frame: Between 2 and 24 hours ]
    The percentage of patients who took acute anti-migraine 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 rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.


Eligibility Criteria
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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:

  • Age from 18 to 65 years 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 the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
  • Migraine onset before the age of 50 years
  • 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 (AE) collecting 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 included Medication Overuse Headache
  • Patients abusing opioids or user of recreational or illicit drugs or has 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 within 30 days of screening visit (Visit 1)
  • Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site
Contacts and Locations
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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): NCT03217968


Locations
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United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Sponsors and Collaborators
Cefaly Technology
Investigators
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Principal Investigator: Joseph MANN, M.D. Rochester Clinical Research, Inc.
  Study Documents (Full-Text)

Documents provided by Cefaly Technology:
Study Protocol and Statistical Analysis Plan  [PDF] June 1, 2017

More Information
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Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT03217968    
Other Study ID Numbers: 50803
First Posted: July 14, 2017    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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