Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

NCT02342743 | Completed Results

• 1 other identifier: 50207
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Frequency of Headache Days

  Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  End of baseline period and end of 12 weeks treatment period

• Change From Baseline in Acute Medication Intake

  Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.

  End of baseline period and end of 12 weeks treatment period

Secondary Outcomes (6)

• Change in Frequency of Migraine Days

  End of baseline period and end of 12 weeks treatment period

• Change in Frequency of Moderate/Severe Headache Days

  End of baseline period and end of 12 weeks treatment period

• Change in Monthly Cumulative Headache Hours

  End of baseline period and end of 12 weeks treatment period

• Change in Frequency of Headache Episodes

  End of baseline period and end of 12 weeks treatment period

• 50% Responder Rate for Migraine Days

  End of the 12 weeks treatment period

Study Arms (1)

Active

EXPERIMENTAL

Daily trigeminal nerve stimulation session of 20 minutes with CEFALY

Device: CEFALY

Interventions

CEFALY DEVICE

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:

• Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.
• Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited

You may not qualify if:

• Women: Pregnant, lactating or \<6 months post partum
• For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
• For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
• Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
• A Beck Depression Inventory score of \>24 at baseline
• Psychiatric disorders that could have interfered with study participation
• Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

Sponsors & Collaborators

• Cefaly Technology: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus - Department of Neurology

Aurora, Colorado, 80045, 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 Trials Department director
• Organization: CEFALY Technology

info@cefaly.com

+3243676722

Study Officials

• Marius Birlea, MD

  Department of Neurology, University of Colorado Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

• Pierre Rigaux

  Cefaly Technology

  STUDY DIRECTOR

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: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: February 2, 2015
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: June 20, 2019
• Results First Posted: September 19, 2018

Record last verified: 2019-06

Locations

US (1)