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Open-trial on the Prevention of Chronic Migraines With the CEFALY 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: NCT02342743
Recruitment Status : Completed
First Posted : January 21, 2015
Results First Posted : September 19, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

Brief Summary:
The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

Condition or disease Intervention/treatment Phase
Migraine Device: CEFALY Not Applicable

Detailed Description:
The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Actual Study Start Date : February 2, 2015
Actual Primary Completion Date : April 11, 2017
Actual Study Completion Date : April 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Active
Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
Device: CEFALY



Primary Outcome Measures :
  1. Change From Baseline in Frequency of Headache Days [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  2. Change From Baseline in Acute Medication Intake [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.


Secondary Outcome Measures :
  1. Change in Frequency of Migraine Days [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  2. Change in Frequency of Moderate/Severe Headache Days [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  3. Change in Monthly Cumulative Headache Hours [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  4. Change in Frequency of Headache Episodes [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  5. 50% Responder Rate for Migraine Days [ Time Frame: End of the 12 weeks treatment period ]
    Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  6. Change in the Average Headache Intensity [ Time Frame: End of baseline period and end of 12 weeks treatment period ]
    Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain).



Information from the National Library of Medicine

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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:

  • Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.

Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited

Exclusion Criteria:

  1. Women: Pregnant, lactating or <6 months post partum
  2. For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
  3. For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
  4. Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
  5. A Beck Depression Inventory score of >24 at baseline
  6. Psychiatric disorders that could have interfered with study participation
  7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

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): NCT02342743


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus - Department of Neurology
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Cefaly Technology
Investigators
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Principal Investigator: Marius Birlea, MD Department of Neurology, University of Colorado Anschutz Medical Campus
Study Director: Pierre Rigaux Cefaly Technology
  Study Documents (Full-Text)

Documents provided by Cefaly Technology:

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Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT02342743    
Other Study ID Numbers: 50207
First Posted: January 21, 2015    Key Record Dates
Results First Posted: September 19, 2018
Last Update Posted: June 20, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases