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

May 5, 2015 updated by: IRCCS National Neurological Institute "C. Mondino" Foundation

Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month on a regular basis for > 3 months.
  2. 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.

Study Type

Interventional

Enrollment (Actual)

690

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 month
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)
6 month
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
12 month
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
24 month
Drop-outs
Time Frame: 24 month
Number of drop-outs in the two arms
24 month
Midas scores
Time Frame: 24 month
Changes in Midas scores in the two arms
24 month
HURT scores
Time Frame: 24 month
Changes in HURT scores in the two arms
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215366

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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