Medication Overuse Headache (MOH) and an Innovative Approach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home Detox in Medication Overuse Headache (MOH) During Covid-19 Emergency

NCT04410536

Migraine, Hemicrania

COMPLETED PHASE4

Comparison of Two Detoxification Protocols for Treatment of Medication-overuse Headache

NCT02903329

Medication-overuse Headache

COMPLETED NA

Is Detoxification Needed in Medication-overuse Headache?

NCT02993289

Medication Overuse Headache

UNKNOWN NA

Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?

NCT00159588

Headache

COMPLETED NA

Medicine Abuse Headache

NCT01170793

Migraine

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Overuse Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Classic Approach

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

Group Type NO_INTERVENTION

No interventions assigned to this group

IEPR Approach

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

Group Type EXPERIMENTAL

IEPR Approach

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Nappi, MD

Role: STUDY_DIRECTOR

IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALY

Rigmor Jensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glostrup Hospital, Copenaghen, Denmark

Zaza Katsarava, MD, PHD, MSc

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum, Essen, Germany

Jorge Leston, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Argentina

Ricardo Fadic, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Miguel JA Lainez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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