- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02435056
Medication Overuse Headache (MOH) and an Innovative Approach (COMOESTAS)
Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Classic Approach
Patient fills in a paper diary in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.)
|
|
Expérimental: IEPR Approach
Patient has to use the electronic diary to record days with headache, acute drugs consumed, etc.
|
Adoption of Interactive Electronic Patient Record (IEPR) that consists of the following clinically-relevant main components:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Relapse Rate Follow up
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Days with headache
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 24 month
|
Number of drop-outs in the two arms
|
24 month
|
Midas scores
Délai: 24 month
|
Changes in Midas scores in the two arms
|
24 month
|
HURT scores
Délai: 24 month
|
Changes in HURT scores in the two arms
|
24 month
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Giuseppe Nappi, MD, IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALY
- Chercheur principal: Rigmor Jensen, MD, PhD, Glostrup Hospital, Copenaghen, Denmark
- Chercheur principal: Zaza Katsarava, MD, PHD, MSc, Universitaetsklinikum, Essen, Germany
- Chercheur principal: Jorge Leston, MD, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Argentina
- Chercheur principal: Ricardo Fadic, MD, Pontificia Universidad Catolica de Chile
- Chercheur principal: 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
- Chercheur principal: Marco Pagani, Manager, Consorzio di Bioingegneria Medica, Pavia, Italy
- Chercheur principal: Nestor Gorini, Ministerio de la Salud de la Provincia de Buenos Aires, Argentina
- Chercheur principal: Santiago Spadafora, Fundacion Isalud, Buenos Aires, Argentina
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 215366
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