NCT02616978

Brief Summary

This is an Internet survey to collect data on the use of the Cefaly device to treat migraine attacks in regular Cefaly users.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
807

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

November 19, 2015

Last Update Submit

May 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack

    On average, mean number of anti-migraine acute drug intake avoided per month per patient in regular Cefaly users, based on self reported average monthly number of attacks and percentage of attacks treated successfully with the Cefaly

    Maximum 1 year

Secondary Outcomes (3)

  • Proportion of Cefaly users that report using also the device to treat migraine attacks

    Maximum 1 year

  • Proportion of migraine attacks treated with the Cefaly device

    Maximum 1 year

  • Proportion of migraine attacks for which the use of the Cefaly device generate a reduction of drug intake

    Maximum 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

French speaking patients in Belgium, Switzerland and France, having ordered new electrodes during the last year will be identified as regular users.

You may qualify if:

  • Subjects using Cefaly device regularly for more than a year identify by reordering of electrodes during the last year.
  • History of likely episodic or chronic migraine with or without aura diagnosed by a physician

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Penning S, Schoenen J. A survey on migraine attack treatment with the CEFALY(R) device in regular users. Acta Neurol Belg. 2017 Jun;117(2):547-549. doi: 10.1007/s13760-017-0757-z. Epub 2017 Feb 9. No abstract available.

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 30, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 8, 2017

Record last verified: 2017-05