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
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
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
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
NCT ID
NCT02435056
First Posted
April 30, 2015
Last Updated
May 5, 2015
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
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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