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Trial record 39 of 1110 for:    migraine

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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Device: Cefaly® Abortive Program device
Enrollment 59
Recruitment Details  
Pre-assignment Details  
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Period Title: Overall Study
Started 59
Completed 48
Not Completed 11
Reason Not Completed
Withdrawal by Subject             4
Lost to Follow-up             1
Protocol Violation             6
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Baseline Participants 48
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
46.85  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
43
  89.6%
Male
5
  10.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Migraine type  
Measure Type: Count of Participants
Unit of measure:  Participants
Migraine with aura Number Analyzed 48 participants
15
  31.3%
Migraine without aura Number Analyzed 48 participants
33
  68.8%
Migraine intensity  
Measure Type: Count of Participants
Unit of measure:  Participants
Moderate intensity at baseline Number Analyzed 48 participants
33
  68.8%
Severe intensity at baseline Number Analyzed 48 participants
15
  31.3%
Most bothersome syndrome  
Measure Type: Count of Participants
Unit of measure:  Participants
Nausea Number Analyzed 48 participants
11
  22.9%
Vomiting Number Analyzed 48 participants
1
   2.1%
Sensitivity to light Number Analyzed 48 participants
27
  56.3%
Sensitivity to sound Number Analyzed 48 participants
9
  18.8%
1.Primary Outcome
Title Pain Freedom (PF) at 2 Hours
Hide Description 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.
Time Frame 2 hours
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[Not Specified]
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
17
  35.4%
2.Primary Outcome
Title Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours
Hide Description 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.
Time Frame 2 hours
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[Not Specified]
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
29
  60.4%
3.Secondary Outcome
Title Pain Relief (PR) at 2 Hours
Hide Description 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.
Time Frame 2 hours
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[Not Specified]
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
34
  70.8%
4.Secondary Outcome
Title Migraine-associated Symptoms Freedom at 2 Hours
Hide Description The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.
Time Frame 2 hours
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[Not Specified]
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
22
  45.8%
5.Secondary Outcome
Title Use of Rescue Medication Between 2 and 24 Hours
Hide Description The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.
Time Frame Between 2 and 24 hours
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[Not Specified]
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
24
  50.0%
6.Secondary Outcome
Title Sustained Pain Freedom at 24 Hours
Hide Description 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.
Time Frame 24 hours
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[Not Specified]
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
12
  25.0%
Time Frame The data was collected during the 24 hours following the start of the treatment
Adverse Event Reporting Description [Not Specified]
 
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120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

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).

All-Cause Mortality
Active
Affected / at Risk (%)
Total   0/59 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active
Affected / at Risk (%) # Events
Total   0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active
Affected / at Risk (%) # Events
Total   15/59 (25.42%)    
Blood and lymphatic system disorders   
Cold feet *  1/59 (1.69%)  1
Nervous system disorders   
Dizziness *  1/59 (1.69%)  1
Nausea *  2/59 (3.39%)  2
Vomiting *  1/59 (1.69%)  1
Pain in the jaw *  1/59 (1.69%)  1
Discomfort in teeth *  1/59 (1.69%)  1
Drowsiness *  1/59 (1.69%)  1
Pain in eyes * [1]  1/59 (1.69%)  1
Skin and subcutaneous tissue disorders   
Burning sensation on the forehead *  7/59 (11.86%)  7
itching/tingling/stinging/numbness sensation on forehead *  4/59 (6.78%)  4
*
Indicates events were collected by non-systematic assessment
[1]
Severe pain in eyes when eyes open while wearing device
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted to the sponsor for review. Sponsor may request:

  • deletion of any trade secret, proprietary, or confidential information of Sponsor
  • an additional 90 days to take measures to preserve its Intellectual Property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Department director
Organization: CEFALY Technology
Phone: +3243676722
EMail: info@cefaly.com
Layout table for additonal information
Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT03217968     History of Changes
Other Study ID Numbers: 50803
First Submitted: July 13, 2017
First Posted: July 14, 2017
Results First Submitted: May 4, 2018
Results First Posted: June 7, 2018
Last Update Posted: August 7, 2018