NCT02590939

Brief Summary

The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 9, 2018

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

October 28, 2015

Results QC Date

February 7, 2018

Last Update Submit

May 4, 2018

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Pain Score 1-hour

    Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline

    1 hour

Secondary Outcomes (4)

  • Rescue Medication 2 Hours

    2 hours

  • Pain Score 2 Hours

    2 hours

  • Rescue Medication 24 Hours

    24 hours

  • Pain Score 24 Hours

    24 hours

Study Arms (2)

Active device

EXPERIMENTAL

60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device

Device: CEFALY Active

Sham device

SHAM COMPARATOR

60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device

Device: CEFALY Placebo

Interventions

CEFALY ActiveDEVICE

Active external trigeminal nerve stimulation

Active device
CEFALY PlaceboDEVICE

Placebo external trigeminal nerve stimulation

Sham device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction)
  • Having a migraine attack lasting at least 3 hours
  • Migraine pain intensity stabilized for at least 1 hour
  • Frontal, retro-, or peri- orbital headache.

You may not qualify if:

  • Pregnant women
  • Patients having received Botox treatment in the prior 4 months
  • Patients having received supraorbital nerve blocks in the prior 4 months
  • Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
  • Patients with only temporal or occipital headache
  • Patients using opioid medication
  • Patients having taken abortive migraine medication in the prior 3 hours
  • Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 5 minutes of neurostimulation).
  • Implanted metal or electrical devices in the head
  • Cardiac pacemaker or implanted or wearable defibrillator
  • Patient having had a previous experience with Cefaly®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Rowe Neurology Institute

Lenexa, Kansas, 66214-9836, United States

Location

Columbia University Medical Center

New York, New York, 10019, United States

Location

Related Publications (1)

  • Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019 Jan;39(1):3-14. doi: 10.1177/0333102418811573. Epub 2018 Nov 17.

    PMID: 30449151DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Clinical Trials Department director
Organization
CEFALY Technology
info@cefaly.com
+32 4 367 67 22

Study Officials

  • Denise Chou, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

February 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

June 6, 2018

Results First Posted

April 9, 2018

Record last verified: 2018-05

Locations

US(3)