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

Migraine Clinical Trial

— TEAM  

Official title:

A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465904
• Other study ID #: 51401
• Status: Completed
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: January 11, 2019

Study information

• Verified date: July 2019
• Source: Cefaly Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: January 11, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rapid Medical Research Inc.	Cleveland	Ohio
United States	Pharmacology Research Institute	Encino	California
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Yale University	New Haven	Connecticut
United States	Rochester Clinical Research	Rochester	New York
United States	Meridian Clinical Research (Rockville Neurology)	Rockville	Maryland
United States	Meridian Clinical Research (Savannah Neurology)	Savannah	Georgia
United States	Clinical Research Consortium	Tempe	Arizona
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cefaly Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Freedom at 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 hours
Primary	Most Bothersome Migraine-associated Symptom Freedom at 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.	2 hours
Secondary	Pain Relief at 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 hours
Secondary	Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours	The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.	2 hours
Secondary	Use of Rescue Medication Between 2 and 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.	2-24 hours
Secondary	Sustained Pain Freedom at 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.	24 hours
Secondary	Sustained Pain Relief at 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.	2-24 hours