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Is Detoxification Needed in Medication-overuse Headache?

Is Detoxification Needed in Medication-overuse Headache?: A Randomized Controlled Trial of 3 Treatment Strategies

NCT02993289•Danish Headache Center

Summary

Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to European guidelines and based on evidence, multidisciplinary detoxification is the first choice of treatment for MOH. However, consensus about the details in such detoxification programs is lacking. Contrary, other headache specialists believe more in treating chronic headache with medication overuse with single-therapy of prophylaxis and no withdrawal of acute medication, based on randomized controlled double-blinded placebo trial with prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to detoxification. However there was no significant difference. AIM: 1. To compare three different treatment protocols in order to improve the therapy of MOH. 2. To test several baseline variables for being potential predictors for good treatment outcome. 3. To examine the role of epigenetics in MOH.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Patients with medication-overuse headache:
•Confirmed MOH diagnosis according to the ICHD-III beta (1).
•Eligible for outpatient treatment based on type of medication overuse (without massive pure opioids and barbiturates overuse), and personal resources and motivation.
•Capable of completing headache diary/calendar.
•Age ≥ 18 years old and capable of providing informed consent.
•Medication-overuse headache based on initial tension-type headache (TTH) or migraine.
•Signed informed consent.

Exclusion Criteria

•Severe physical illness or psychiatric disorders.
•Addiction to alcohol or other drugs.
•Current treatment with headache prophylaxis. Patients can be included minimum 5 weeks after stop of prophylaxis.
•Pregnancy, breastfeeding or planned pregnancy within the next 12 months.
•Inability to provide reliable information about medical history.
•Criteria for Control group 1 - Episodic migraineurs:
•Episodic migraine, with/without concomitant tension-type headache, according to the ICHD-III beta.
•Headache days / month ≤ 6 at time of inclusion.
•Days with analgesics / month ≤ 6 at time of inclusion.
•Prophylactics are allowed.
+13 more criteria

Locations (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, Denmark

Key Dates

Start Date

October 24, 2016

Primary Completion Date

July 2, 2019

Completion Date

November 30, 2023

Last Updated

June 11, 2020

Enrollment

115

ESTIMATED participants

Conditions

Medication Overuse Headache

Interventions

Different well-known treatments

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.