Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

Migraine Clinical Trial

Official title:

Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217968
• Other study ID #: 50803
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: July 2018
• Source: Cefaly Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	Rochester Clinical Research, Inc.	Rochester	New York

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 (PF) 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 (MBS) 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 (PR) 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	Migraine-associated Symptoms Freedom at 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.	2 hours
Secondary	Use of Rescue Medication 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.	Between 2 and 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 rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.	24 hours