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Medication Overuse Headache (MOH) and an Innovative Approach (COMOESTAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02435056
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary:
Appropriate delivery of quality healthcare requires constant monitoring of the patient during follow up, particularly in the presence of chronic diseases. This approach can be further improved if leading edge tools supporting diagnosis, as well as prediction, identification and monitoring of adverse events are available. COMOESTAS aims to develop an innovative Information Communications Technology (ICT) system that allows patients with a chronic condition to receive continuous and personalized treatment. The whole system is based on an advanced, "all in one" Alerting and Decision Support System that follows patients from the diagnosis and supports the physician in managing the therapy, controlling relevant events impacting on patient safety and activating specific procedures if selected thresholds are exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH) is a common condition and a major cause of disability. MOH is curable, but its outcome is hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that can benefit from an ICT-assisted approach developing innovative systems and services for monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating the traditional paper headache diaries and calendars into an innovative ICT tool taking into account the complex issues that accompany this peculiar form of headache, which will make the patient a key node in the entire process.

Condition or disease Intervention/treatment Phase
Medication Overuse Headache Other: IEPR Approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 690 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System
Study Start Date : July 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Classic Approach
Patient fills in a paper diary in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.)
Experimental: IEPR Approach
Patient has to use the electronic diary to record days with headache, acute drugs consumed, etc.
Other: IEPR Approach

Adoption of Interactive Electronic Patient Record (IEPR) that consists of the following clinically-relevant main components:

  • Minimum Data Set for supporting the diagnosis
  • Electronic Diary with associated alerting system for monitoring the patient during the follow-up period
  • Second opinion system for improving the management

Primary Outcome Measures :
  1. Relapse Rate Follow up [ Time Frame: 6 month ]
    Relapse Rate 6 months after withdrawal of patients with medication overuse. Relapse will be defined as use of ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month or use of simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on > 15 days/month during the previous month, with the exclusion of month +1.

Secondary Outcome Measures :
  1. Days with headache [ Time Frame: 6 month ]
    Number of days with headache before and after detoxification in the two arms (month -1 vs. month +6)

  2. Days per month with migraine [ Time Frame: 6 month ]
    Number of days per month with migraine before and after detoxification in the two arms (month -1 vs. month +6)

  3. MOH patients/total number of headache [ Time Frame: 12 month ]
    Number of MOH patients/total number of headache patients during the recruitment period (6-12 months ) of the two arms

  4. MOH patients/total number of headache [ Time Frame: 24 month ]
    Number of MOH patients/total number of headache patients during the recruitment period (18-24 months ) of the two arms

  5. Drop-outs [ Time Frame: 24 month ]
    Number of drop-outs in the two arms

  6. Midas scores [ Time Frame: 24 month ]
    Changes in Midas scores in the two arms

  7. HURT scores [ Time Frame: 24 month ]
    Changes in HURT scores in the two arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with MOH

Exclusion Criteria:

  1. a current diagnosis of co-existent, significant and complicating medical or psychiatric illnesses
  2. significant overuse of "pure" opioids (patients overusing combination drugs containing opioids are allowed), benzodiazepines, and barbiturates,
  3. overuse of alcohol and other drugs of addiction,
  4. current treatment with migraine prophylactic drugs
  5. inefficacy of previous adequate detoxification programmes
  6. inability to provide reliable information about medical history
  7. pregnancy or breast feeding
  8. inability to learn how to use paper or electronic diaries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02435056

Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
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Study Director: Giuseppe Nappi, MD IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALY
Principal Investigator: Rigmor Jensen, MD, PhD Glostrup Hospital, Copenaghen, Denmark
Principal Investigator: Zaza Katsarava, MD, PHD, MSc Universitaetsklinikum, Essen, Germany
Principal Investigator: Jorge Leston, MD Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Argentina
Principal Investigator: Ricardo Fadic, MD Pontificia Universidad Catolica de Chile
Principal Investigator: Miguel JA Lainez, MD, PhD Fundacion de la Comunidad Valenciana para la Investigacion Biomedica, la Docencia Y la Cooperacion Internacional y para el Desarrollo del Hospital Clinico Universitario De Valencia, Spain
Principal Investigator: Marco Pagani, Manager Consorzio di Bioingegneria Medica, Pavia, Italy
Principal Investigator: Nestor Gorini Ministerio de la Salud de la Provincia de Buenos Aires, Argentina
Principal Investigator: Santiago Spadafora Fundacion Isalud, Buenos Aires, Argentina
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation Identifier: NCT02435056    
Other Study ID Numbers: 215366
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
medication overuse headache
health care system
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Neurologic Manifestations
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases