Clinical Trial: Medication Overuse Headache (MOH) and an Innovative Approach

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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 Cen
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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)
  • 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
  • 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
  • Drop-outs [ Time Frame: 24 month ]
    Number of drop-outs in the two arms
  • Midas scores [ Time Frame: 24 month ]
    Changes in Midas scores in the two arms
  • HURT scores [ Time Frame: 24 month ]
    Changes in HURT scores in the two arms


Original Secondary Outcome: Same as current

Information By: IRCCS National Neurological Institute "C. Mondino" Foundation

Dates:
Date Received: April 30, 2015
Date Started: July 2008
Date Completion:
Last Updated: May 5, 2015
Last Verified: April 2015