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

Primary Purpose

Medication Overuse Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IEPR Approach
Sponsored by
IRCCS National Neurological Institute "C. Mondino" Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Medication Overuse Headache focused on measuring medication overuse headache, health care system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Classic Approach

    IEPR Approach

    Arm Description

    Patient fills in a paper diary in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.)

    Patient has to use the electronic diary to record days with headache, acute drugs consumed, etc.

    Outcomes

    Primary Outcome Measures

    Relapse Rate Follow up
    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

    Days with headache
    Number of days with headache before and after detoxification in the two arms (month -1 vs. month +6)
    Days per month with migraine
    Number of days per month with migraine before and after detoxification in the two arms (month -1 vs. month +6)
    MOH patients/total number of headache
    Number of MOH patients/total number of headache patients during the recruitment period (6-12 months ) of the two arms
    MOH patients/total number of headache
    Number of MOH patients/total number of headache patients during the recruitment period (18-24 months ) of the two arms
    Drop-outs
    Number of drop-outs in the two arms
    Midas scores
    Changes in Midas scores in the two arms
    HURT scores
    Changes in HURT scores in the two arms

    Full Information

    First Posted
    April 30, 2015
    Last Updated
    May 5, 2015
    Sponsor
    IRCCS National Neurological Institute "C. Mondino" Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02435056
    Brief Title
    Medication Overuse Headache (MOH) and an Innovative Approach
    Acronym
    COMOESTAS
    Official Title
    Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    IRCCS National Neurological Institute "C. Mondino" Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    It will be a multicentre parallel group study. The two arms of the clinical protocol will be 1) classic approach to MOH and 2) Interactive Electronic Patient Record (IEPR)-based approach to MOH. Each arm will last 12 months. MOH will be diagnosed according to the 2006 MOH-R criteria of the International Headache Society as reported below: A. Headache present on > 15 days/month. B. Regular overuse for > 3 months of one or more acute symptomatic drugs: Ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month on a regular basis for > 3 months. Simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on > 15 days/month on a regular basis for >3 months without overuse (> 10 days) of any single class alone. C. Headache has developed or markedly worsened during medication overuse. The IEPR approach will be preliminarily tested and validated in small groups of patients during months 6-12 (pilot validation). Each patient will be evaluated over a period of 7 months. Classic approach Visit 0: patient is examined and, if suspected to suffer from MOH, is asked to fill in a diary for a month in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.). Patient has to report that MOH-R criteria were fulfilled for the previous 2 months. Visit 1: Patient returns to the Centre, diary data are analyzed and recorded, and, if criteria for MOH-R diagnosis are fulfilled and exclusion criteria are ruled out , patient is enrolled in COMOESTAS protocol. Detoxification: following visit 1, patient undergoes detoxification according to the protocol in Appendix 1. In the subsequent 2 months the patient is instructed to record headache characteristics and consumption of symptomatic drugs on a paper diary. Visit 2 (2 months after detoxification): patient is visited again; diary is checked; if therapy is successful (patient no longer overuses acute medications for headache) the patient is scheduled for a follow-up visit after 4 months. The patient is asked to keep up recording headache characteristics and consumption of symptomatic drugs on a paper diary for the next 4 months and informed about a telephone contact after 2 months. Visit 3 (6 months after detoxification): patient is visited again, diary data are collected. Study ends. IEPR approach Visit 0: patient is examined and, if the minimum data set of the IEPR for MOH is satisfied, the patients is asked to record the headache characteristics as well as acute drugs consumption on a paper diary for a month in order to assess baseline parameters of MOH (days with headache, acute drugs consumed, etc.). Patient has to report that MOH-R criteria were fulfilled for the previous 2 months. Visit 1: Patient returns to the Centre, diary data are analyzed and recorded, and, if criteria for MOH diagnosis are confirmed and criteria of exclusion are ruled out, patient is enrolled in COMOESTAS protocol . Detoxification: following Visit 1, patient undergoes detoxification according to the same protocol adopted for the classic approach. During the detoxification phase, the patient is instructed to use the electronic diary and is then asked to fill the electronic diary on a regular basis (preferably daily or at least weekly) for the next 6 months. Visit 2 (2 months after detoxification): patient is visited again; if therapy is successful (patient no longer overuses acute medications for headache), MOH diagnosis the patient is scheduled for a follow-up visit after 4 months and informed about a telephone contact after 2 months. The patient is asked to keep up filling the electronic diary for the next 4 months. Visit 3: the patient is visited again. Study ends.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Medication Overuse Headache
    Keywords
    medication overuse headache, health care system

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    690 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Classic Approach
    Arm Type
    No Intervention
    Arm Description
    Patient fills in a paper diary in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.)
    Arm Title
    IEPR Approach
    Arm Type
    Experimental
    Arm Description
    Patient has to use the electronic diary to record days with headache, acute drugs consumed, etc.
    Intervention Type
    Other
    Intervention Name(s)
    IEPR Approach
    Intervention Description
    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 Measure Information:
    Title
    Relapse Rate Follow up
    Description
    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.
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Days with headache
    Description
    Number of days with headache before and after detoxification in the two arms (month -1 vs. month +6)
    Time Frame
    6 month
    Title
    Days per month with migraine
    Description
    Number of days per month with migraine before and after detoxification in the two arms (month -1 vs. month +6)
    Time Frame
    6 month
    Title
    MOH patients/total number of headache
    Description
    Number of MOH patients/total number of headache patients during the recruitment period (6-12 months ) of the two arms
    Time Frame
    12 month
    Title
    MOH patients/total number of headache
    Description
    Number of MOH patients/total number of headache patients during the recruitment period (18-24 months ) of the two arms
    Time Frame
    24 month
    Title
    Drop-outs
    Description
    Number of drop-outs in the two arms
    Time Frame
    24 month
    Title
    Midas scores
    Description
    Changes in Midas scores in the two arms
    Time Frame
    24 month
    Title
    HURT scores
    Description
    Changes in HURT scores in the two arms
    Time Frame
    24 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with MOH Exclusion Criteria: a current diagnosis of co-existent, significant and complicating medical or psychiatric illnesses significant overuse of "pure" opioids (patients overusing combination drugs containing opioids are allowed), benzodiazepines, and barbiturates, overuse of alcohol and other drugs of addiction, current treatment with migraine prophylactic drugs inefficacy of previous adequate detoxification programmes inability to provide reliable information about medical history pregnancy or breast feeding inability to learn how to use paper or electronic diaries
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giuseppe Nappi, MD
    Organizational Affiliation
    IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALY
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Rigmor Jensen, MD, PhD
    Organizational Affiliation
    Glostrup Hospital, Copenaghen, Denmark
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Zaza Katsarava, MD, PHD, MSc
    Organizational Affiliation
    Universitaetsklinikum, Essen, Germany
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jorge Leston, MD
    Organizational Affiliation
    Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Argentina
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ricardo Fadic, MD
    Organizational Affiliation
    Pontificia Universidad Catolica de Chile
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Miguel JA Lainez, MD, PhD
    Organizational Affiliation
    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
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marco Pagani, Manager
    Organizational Affiliation
    Consorzio di Bioingegneria Medica, Pavia, Italy
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nestor Gorini
    Organizational Affiliation
    Ministerio de la Salud de la Provincia de Buenos Aires, Argentina
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Santiago Spadafora
    Organizational Affiliation
    Fundacion Isalud, Buenos Aires, Argentina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16919060
    Citation
    Rossi P, Di Lorenzo C, Faroni J, Cesarino F, Nappi G. Advice alone vs. structured detoxification programmes for medication overuse headache: a prospective, randomized, open-label trial in transformed migraine patients with low medical needs. Cephalalgia. 2006 Sep;26(9):1097-105. doi: 10.1111/j.1468-2982.2006.01175.x.
    Results Reference
    background
    PubMed Identifier
    15261608
    Citation
    Diener HC, Limmroth V. Medication-overuse headache: a worldwide problem. Lancet Neurol. 2004 Aug;3(8):475-83. doi: 10.1016/S1474-4422(04)00824-5.
    Results Reference
    background
    PubMed Identifier
    16961785
    Citation
    Zeeberg P, Olesen J, Jensen R. Discontinuation of medication overuse in headache patients: recovery of therapeutic responsiveness. Cephalalgia. 2006 Oct;26(10):1192-8. doi: 10.1111/j.1468-2982.2006.01190.x.
    Results Reference
    background
    PubMed Identifier
    16707727
    Citation
    Zeeberg P, Olesen J, Jensen R. Probable medication-overuse headache: the effect of a 2-month drug-free period. Neurology. 2006 Jun 27;66(12):1894-8. doi: 10.1212/01.wnl.0000217914.30994.bd. Epub 2006 May 17.
    Results Reference
    background
    PubMed Identifier
    12799950
    Citation
    Haag G, Baar H, Grotemeyer KH, Pfaffenrath V, Ribbat MJ, Diener HC. [Prophylaxis and treatment of drug-induced persistent headache. Therapy recommendation of the German Society for Migraine and Headache]. Schmerz. 1999 Feb 18;13(1):52-7. doi: 10.1007/s004829900016. No abstract available. German.
    Results Reference
    background
    PubMed Identifier
    16686915
    Citation
    Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.
    Results Reference
    background
    PubMed Identifier
    29984608
    Citation
    Jellestad PL, Carlsen LN, Westergaard ML, Munksgaard SB, Bendtsen L, Lainez M, Fadic R, Katsarava Z, Goicochea MT, Spadafora S, Jensen RH, Nappi G, Tassorelli C; COMOESTAS Consortium. Economic benefits of treating medication-overuse headache - results from the multicenter COMOESTAS project. Cephalalgia. 2019 Feb;39(2):274-285. doi: 10.1177/0333102418786265. Epub 2018 Jul 8. Erratum In: Cephalalgia. 2019 Oct;39(11):1472.
    Results Reference
    derived
    PubMed Identifier
    27440251
    Citation
    Tassorelli C, Jensen R, Allena M, De Icco R, Katsarava Z, Miguel Lainez J, Leston JA, Fadic R, Spadafora S, Pagani M, Nappi G; COMOESTAS Consortium. The added value of an electronic monitoring and alerting system in the management of medication-overuse headache: A controlled multicentre study. Cephalalgia. 2017 Oct;37(12):1115-1125. doi: 10.1177/0333102416660549. Epub 2016 Jul 20.
    Results Reference
    derived

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    Medication Overuse Headache (MOH) and an Innovative Approach

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