Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

NCT03217968 | Completed Results FDA Device

• 1 other identifier: 50803
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Pain Relief (PR) at 2 Hours

  2 hours

• Migraine-associated Symptoms Freedom at 2 Hours

  2 hours

• Use of Rescue Medication Between 2 and 24 Hours

  Between 2 and 24 hours

• Sustained Pain Freedom at 24 Hours

  24 hours

Study Arms (1)

Active

EXPERIMENTAL

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

Device: Cefaly® Abortive Program device

Interventions

Cefaly® Abortive Program device DEVICE

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

Active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cefaly Technology: lead

Study Sites (1)

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Trial Department director
• Organization: CEFALY Technology

info@cefaly.com

+3243676722

Study Officials

• Joseph MANN, M.D.

  Rochester Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 14, 2017
• Study Start: August 10, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: August 7, 2018
• Results First Posted: June 7, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)