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Clinical Trials/DRKS00025961
DRKS00025961
Recruiting
未知

Prevention of Medication Overuse (MO) and Medication Overuse Headache (MOH): A randomized, controlled, parallel, multicenter, prospective trial using a mobile application software - MOH

niversitätsklinikum Essen in Wahrnehmung der Aufgaben der Universität Duisburg-Essen, Campus Essen, Fachbereich Medizin; Institution: Institut für Medizinische Informatik, Biometrie und Epidemiologie0 sites960 target enrollmentAugust 4, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
G43
Sponsor
niversitätsklinikum Essen in Wahrnehmung der Aufgaben der Universität Duisburg-Essen, Campus Essen, Fachbereich Medizin; Institution: Institut für Medizinische Informatik, Biometrie und Epidemiologie
Enrollment
960
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversitätsklinikum Essen in Wahrnehmung der Aufgaben der Universität Duisburg-Essen, Campus Essen, Fachbereich Medizin; Institution: Institut für Medizinische Informatik, Biometrie und Epidemiologie

Eligibility Criteria

Inclusion Criteria

  • 1\) Migraine patients: Patients with frequent episodic migraine (EM) (\= 8\-14 headache days/month, of which 4 fulfill IHS criteria for migraine) or chronic migraine (CM) (\=15 headache days/month, of which 8 fulfill IHS criteria for migraine)
  • Post\-MO(H)\-Patients: Patients, who underwent treatment for MO(H) (initially \= 15 headache days/month, intake of attack aborting medication on 10 or more or 15 or more days/month according to International Classification of Headache Disorders (ICHD\-3\) criteria of mediation overuse headache (MOH))
  • 2\) Owning a mobile device with iOS or Android system, which is able to run the App
  • 3\) Adults \= 18 years
  • 4\) Written informed consent consistent with ICH\-GCP (International Conference of Harmonization – Good Clinical Practice) guidelines and local laws signed prior to all study\-related procedures
  • 5\) Compliance for using the App on \= 80% days during the screening period

Exclusion Criteria

  • 1\) Patients with concomitant primary headache disorders, other than EM or CM (except tension\-type headache \< 15 days/month)
  • 2\) Current MO upon the discretion of the treating physician (intake of attack aborting medication on \=10 days/month within the last 3 months)
  • 3\) Co\-morbidity interfering with the study outcomes upon the discretion of the treating physician
  • 4\) Intake of opioids on \> 3 days/month
  • 5\) Regular intake (\> 15 days/month) of (i) hypnotics, (ii) benzodiazepines as sedatives (tranquillizer), (iii) antipsychotics (neuroleptics) in psychiatric indication
  • 6\) Parallel use of other migraine apps to track headache days and medication intake

Outcomes

Primary Outcomes

Not specified

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