Back to resultsOpen-trial on the Prevention of Chronic Migraines With the CEFALY Device
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CEFALY
Sponsored by
About this trial
This is an interventional prevention trial for Migraine
Eligibility 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:
- Women: Pregnant, lactating or <6 months post partum
- 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.
- For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
- Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
- A Beck Depression Inventory score of >24 at baseline
- Psychiatric disorders that could have interfered with study participation
- Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)
Sites / Locations
- University of Colorado Anschutz Medical Campus - Department of Neurology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
Outcomes
Primary Outcome Measures
Change From Baseline in Frequency of Headache Days
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.
Change From Baseline in Acute Medication Intake
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
Change in Frequency of Migraine Days
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.
Change in Frequency of Moderate/Severe Headache Days
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.
Change in Monthly Cumulative Headache Hours
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.
Change in Frequency of Headache Episodes
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.
50% Responder Rate for Migraine Days
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.
Change in the Average Headache Intensity
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02342743
Brief Title
Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Official Title
Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
April 11, 2017 (Actual)
Study Completion Date
April 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cefaly Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
Intervention Type
Device
Intervention Name(s)
CEFALY
Primary Outcome Measure Information:
Title
Change From Baseline in Frequency of Headache Days
Description
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.
Time Frame
End of baseline period and end of 12 weeks treatment period
Title
Change From Baseline in Acute Medication Intake
Description
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.
Time Frame
End of baseline period and end of 12 weeks treatment period
Secondary Outcome Measure Information:
Title
Change in Frequency of Migraine Days
Description
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.
Time Frame
End of baseline period and end of 12 weeks treatment period
Title
Change in Frequency of Moderate/Severe Headache Days
Description
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.
Time Frame
End of baseline period and end of 12 weeks treatment period
Title
Change in Monthly Cumulative Headache Hours
Description
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.
Time Frame
End of baseline period and end of 12 weeks treatment period
Title
Change in Frequency of Headache Episodes
Description
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.
Time Frame
End of baseline period and end of 12 weeks treatment period
Title
50% Responder Rate for Migraine Days
Description
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.
Time Frame
End of the 12 weeks treatment period
Title
Change in the Average Headache Intensity
Description
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).
Time Frame
End of baseline period and end of 12 weeks treatment period
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:
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:
Women: Pregnant, lactating or <6 months post partum
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.
For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
A Beck Depression Inventory score of >24 at baseline
Psychiatric disorders that could have interfered with study participation
Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Birlea, MD
Organizational Affiliation
Department of Neurology, University of Colorado Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Rigaux
Organizational Affiliation
Cefaly Technology
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus - Department of Neurology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
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