Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

NCT ID: NCT03217968

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2018-01-10

Brief 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.

Detailed 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.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

Group Type: EXPERIMENTAL

Cefaly® Abortive Program device

Intervention Type: DEVICE

The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cefaly Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph MANN, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rochester Clinical Research

Locations

Rochester Clinical Research, Inc.

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

50803

Identifier Type: -

Identifier Source: org_study_id