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

January 21, 2025 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Home-withdrawal Program Combined with Behavioural Approach in Patients with Medication Overuse Headache During Covid-19 Emergency: Incidence of Relapses in Overuse and Changes in Impact At One Year Follow Up

Medication Overuse Headache (MOH) is a disabling condition that affects the 2% of migraine population. Medication overuse (MO) makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse, but it is also confirmed that patients have to be carefully followed after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. Clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, the regular clinical practice adopted for patients with CM-MO has changed in the last weeks: patients cannot come to the hospital for the withdrawal iv therapy and for regular follow up as the reduced mobility due to the emergency in particular in the Lombardia region, but all over Italy. So the investigators propose a pilot study to enforce the application of a Home-program for the withdrawal procedure for patients and the use of technology like smartphone and video calls so that patients can continue to be followed in their therapeutic process by using behavioral support and mindfulness practice. Patients will perform the withdrawal program at home, by oral administration of therapies, with specific instructions and education. Also the information for behavioral approach and mindfulness practice will be given, to use every day at home. Daily standardized mindfulness sessions of 12 minutes on their smartphone will be combined with weekly video-call to evaluate the clinical condition and to encourage the use strategies for pain management. Face-to-face visits at the follow up every three months will be scheduled. This modality will allow the patients to continue their therapeutic process and to be regularly followed during the one year after withdrawal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background and significance Medication Overuse Headache (MOH) is a disabling pain syndrome with a prevalence of 2% in the general population, and which affects patients suffering from primary headaches, mainly those with Chronic Migraine (CM). This condition is very difficult to treat. The literature of the last decades confirmed the need to stop overuse through withdrawal (or detoxification programs) as an essential step in the treatment strategy , and high rates of successful outcomes are reported by several studies and reviews, although not all patients receiving treatment are able to stop MO or to reduce significantly the frequency of headaches. Remission rates range from 60% to 83% in studies with a 1-year follow-up, with an average relapse rate into MOH of 32.8% in a review on several studies from different countries, which is similar to the relapse into CM of 21.5% and into MOH of 33.9% found in a sample from our group . Literature data showed that patients need to be carefully followed after withdrawal to avoid relapses in overuse and to improve the clinical benefit, adding anti-migraine prophylaxi . Furthermore, different clinical experiences confirmed the effectiveness of interventions based on out-patient withdrawal programs and education and support to the correct use of medications to patients, and published evidence - also from our research group - supports the role of standardized behavioural approaches . The aspect of feasibility of these treatments is not regularly reported in published studies, but it can be estimated that a proportion of patients discontinue the treatment protocols, with a drop-out rate around 15-20% at one year from withdrawal., as it was 11% after 6 months, and 18% after 1 year in the seminal study by Katsarawa et al, and 9% after one year from withdrawal in a previous study from our research group . According to our protocols at the Headache Center, the withdrawal program is performed at hospital, either in an in-patient setting or in day-hospital setting. This program includes abrupt interruption of the overused drugs, intravenous therapy, educational support, rescue treatments for severe headaches, and prescription of a specific pharmacological prophylaxis for migraine prevention. Furthermore, standardized behavioural therapies are used during the treatment period, and during the follow up, particularly by approaches based on mindfulness practice - which usually delivered in groups of 4 - 8 patients . This approach may be particularly useful in helping patients to obtain a better outcome. All the above discussed considerations are even more relevant in this emergency situation due to the Corona-virus pandemic phenomenon in Italy, with its consequences on mobility of patients and clinical practice. In order to promote different modalities to respond to the needs of patients suffering from this disabling condition during the emergency, exercise-based telemedicine and smartphone applications seem very appropriate, as they have been recently tested in the management of chronic pain conditions . This preliminary study will be performed considering that the Covid-19 emergency reduced significantly our possibility to hospitalize patients for withdrawal treatments as well as the mobility of patients, particularly those living in other Italian regions than Lombardy, and in view of providing an effective and somewhat innovative treatment program for MOH and CM patients. The proposed treatment intervention is based on our experience, and on published reports, but it specifically includes a home based withdrawal program, several visits performed as Video calls, and educational and support strategies aimed to develop skills to reduce overuse and to cope with pain by a standardized behavioural approach based on mindfulness - which will be delivered mainly by telemedicine and smartphone applications. The aim of this pilot study is to assess the feasibility and the effectiveness at long-term on relevant outcomes of a specific protocol, designed to be appropriate during the emergency situation due to COVID-19 epidemic, by an approach that is alternative to current practice, particularly as far as avoiding the need for hospitalization, reducing face-to-face hospital visits taking advantage of facilities offered by new technologies, besides including innovative and emerging treatment choices, namely a behavioural approach base on mindfulness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

age >18 yrs diagnosis of MOH and CM (1) written informed consent

Exclusion Criteria:

co-existent severe medical or psychiatric illnesses, documented by specific previous diagnoses seizures use of opioids

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Symptomatic drugs - bridge theray - mindfu
  1. abrupt withdrawal of overuse symptomatic drugs, with possibility to use indomethacin suppository 50-100 mg or an oral triptan, on maximum 3 days/10 days, only in case of very severe headache- and to use metoclopramide i.m. injection in case of vomiting;
  2. oral administration of a bridge therapy to reduce the withdrawal symptoms and rebound headache (prednisone 25 mg , 2 tablets after breakfast for 5 days, one tablet for 3 days, half tablet for 2 days ; bromazepam 1.5 mg, 1 tablet after breakfast, lunch and dinner for every day; pantoprazole 40 mg, 1 tablet after dinner every day);
  3. mindfulness practice daily with standard sessions by smartphone 6 minutes per day.
Drug: Symptomatic drugs
indomethacin suppository 50-100 mg or an oral triptan, on maximum 3 days/10 days, only in case of very severe headache- and to use metoclopramide
Drug: Bridge therapy
prednisone 25 mg , 2 tablets after breakfast for 5 days, one tablet for 3 days, half tablet for 2 days ; bromazepam 1.5 mg, 1 tablet after breakfast, lunch and dinner for every day; pantoprazole 40 mg, 1 tablet after dinner every day
Behavioral: Mindfulness program
home based withdrawal program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Drop out rates
Time Frame: at 12 months
Drop-out rates after withdrawal treatment
at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absence of Medication Overuse Headache (MOH)
Time Frame: at 12 months from withdrawal program (assessed by Daily Diary Card)
Percentages of patients with absence of Medication Overuse Headache
at 12 months from withdrawal program (assessed by Daily Diary Card)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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