Medication Overuse Headache (MOH) and an Innovative Approach

NCT02435056 | Completed

• 1 other identifier: 215366
• Study Type: interventional
• Target: 690
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Overuse Headache

Keywords

medication overuse headache; health care system

Outcome Measures

Primary Outcomes (1)

• 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.

  6 month

Secondary Outcomes (7)

• Days with headache

  6 month

• Days per month with migraine

  6 month

• MOH patients/total number of headache

  12 month

• MOH patients/total number of headache

  24 month

• Drop-outs

  24 month

Study Arms (2)

Classic Approach

NO INTERVENTION

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

IEPR Approach

EXPERIMENTAL

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

Other: IEPR Approach

Interventions

IEPR Approach 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

IEPR Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with MOH

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Related Publications (8)

• 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.

  PMID: 16919060 BACKGROUND

• 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.

  PMID: 15261608 BACKGROUND

• 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.

  PMID: 16961785 BACKGROUND

• 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.

  PMID: 16707727 BACKGROUND

• 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.

  PMID: 12799950 BACKGROUND

• 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.

  PMID: 16686915 BACKGROUND

• 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.

  PMID: 29984608 DERIVED

• 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.

  PMID: 27440251 DERIVED

MeSH Terms

Conditions

Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Giuseppe Nappi, MD

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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 6, 2015
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: June 1, 2010
• Last Updated: May 6, 2015

Record last verified: 2015-04