Trial document




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  DRKS00021081

Trial Description

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Title

DMKG Headache Registry

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Headache disorders and migraine are associated with reduced quality of life and important disability in daily and professional life. Because they lead to missed days at work or less efficient work, headache disorders also have a large impact on national economy. Nonetheless, headache disorders receive little public awareness. There are only few data on the quality of medical care for headache patients. However, it is clear that medical care for headache patients in Germany has to be improved.
For improvement of medical care and for collection of reliable data on treatment of headache patients in Germany, the German Migraine and Headache Society (Deutsche Migräne- und Kopfschmerzgesellschaft, DMKG) has developed the independent DMKG Headache Registry.
The DMKG Headache Registry has the following goals:
- To assist physicians with establishing the diagnosis and treatment of headache patients
- To generate data on medical care of headache patients in Germany, which will allow targeted interventions to improve medical care

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Brief Summary in Scientific Language

None withstanding the large prevalence of headache disorders and the important disability associated with headache, medical care of persons with frequent headaches in Germany is insufficient. To improve medical care for headache patients in Germany and to generate data for headache research, the German Migraine and Headache Society (Deutsche Migräne- und Kopfschmerzgesellschaft, DMKG) establishes the DMKG Headache Registry. Before each standard care visit with a participating physician, patients will be asked to enter information on their headache, current and past treatments, and concomitant disorders and medication via the patient web portal and use a dedicated app as headache calendar. During the appointment, the physician has access to the entered information that will be presented in structured form and can be confirmed, supplemented or changed. Automated decision processes regarding diagnosis, investigations or treatment are not provided by the registry. These fall exclusively within the responsibility of the treating physician. Data will be transferred in pseudonymized form to a research database, used by the German Migraine and Headache Society for scientific purposes. Only completely anonymized data will be transferred to third parties (upon application).

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021081
  •   2020/03/25
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  •   yes
  •   Approved
  •   20-004, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1249-5289 
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Health Condition or Problem studied

  •   All headache and facial pain disorders
  •   G43 -  Migraine
  •   G44 -  Other headache syndromes
  •   G50 -  Disorders of trigeminal nerve
  •   G52 -  Disorders of other cranial nerves
  •   R51 -  Headache
  •   M54.2 -  Cervicalgia
  •   M79 -  Other soft tissue disorders, not elsewhere classified
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Interventions/Observational Groups

  •   This is a registry of patients with headache and/ or facial pain disorders. All patients with headache and/or facial pain disorders who are being treated in one of the participating practices/headache centers can be enrolled. Data on headache and headache treatment will be entered by the patient and by the treating physician. The registry only documents the patients' treatment as performed by the physician. There is no study intervention.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Aims of the registry are:
- to improve medical care for headache patients in Germany
and
- to generate data for headache research, especially research on medical care of headache patients.
Possible scientific questions which can be targeted by using data from the registry are:

- How many migraine patients are using triptans?
- How many migraine patients with an indication for a migraine preventive medication actually use preventive medication?
- Quantification of adherence and reasons for termination of headache preventive medication
- Does the effect of headache preventive medication persist after termination of the medication?
- Identification of predictors for efficacy of headache preventive medication

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Secondary Outcome

not applicable (registry)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/06/26
  •   5000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with headache disorders presenting at an institution (private practice or outpatient/inpatient headache center) participating in the German headache registry

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Exclusion Criteria

none

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Addresses

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Sources of Monetary or Material Support

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    • Deutsche Migräne- und Kopfschmerzgesellschaft e.V.
    • Ölmühlweg 31
    • 61462  Königstein im Taunus
    • Germany
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    •   [---]*
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    •   info at dmkg.de
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    • Novartis Pharma GmbH
    • Roonstr. 25
    • 90429  Nürnberg
    • Germany
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    • Teva GmbH
    • Graf-Arco-Str. 3
    • 89079  Ulm
    • Germany
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    • Lilly Deutschland GmbH
    • Werner-Reimers-Str. 2-4
    • 61352  Bad Homburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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