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

NCT04410536 | Completed Phase 4

• 1 other identifier: MOH
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine, Hemicrania

Outcome Measures

Primary Outcomes (1)

• Drop out rates

  Drop-out rates after withdrawal treatment

  at 12 months

Secondary Outcomes (1)

• Absence of Medication Overuse Headache (MOH)

  at 12 months from withdrawal program (assessed by Daily Diary Card)

Study Arms (1)

Symptomatic drugs - bridge theray - mindfu

OTHER

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; Drug: Bridge therapy; Behavioral: Mindfulness program

Interventions

Symptomatic drugs DRUG

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

Symptomatic drugs - bridge theray - mindfu

Bridge therapy DRUG

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

Symptomatic drugs - bridge theray - mindfu

Mindfulness program BEHAVIORAL

home based withdrawal program

Symptomatic drugs - bridge theray - mindfu

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

Milan, Milano, 20133, Italy

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Bridge Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: withdrawal program will be performed at home

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 1, 2020
• Study Start: June 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)