Is Detoxification Needed in Medication-overuse Headache?

NCT02993289 | Unknown

• 1 other identifier: H-16029763
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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. 1.To compare three different treatment protocols in order to improve the therapy of MOH.
2. 2.To test several baseline variables for being potential predictors for good treatment outcome.
3. 3.To examine the role of epigenetics in MOH.

Conditions

Medication Overuse Headache

Outcome Measures

Primary Outcomes (1)

• Reduction in headache days per month in group A and C compared to group B.

  Six months follow-up

Secondary Outcomes (12)

• Reduction in headache days per month

  Two and 12 months follow-up and 4 years

• Reduction in days/month with use of analgesics and/or migraine medication.

  Two, 6 and 12 months follow-up and 4 years

• Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%).

  Two, 6 and 12 months follow-up and 4 years

• Reduction in headache intensity.

  Two, 6 and 12 months follow-up and 4 years

• Descriptive report of self-reported adverse effects of treatments.

  Two, 6 and 12 months follow-up

Other Outcomes (3)

• Difference in DNA-profile between patients with MOH and controlgroups.

  Baseline

• Difference in methylation levels and RNA sequence analysis in patients with MOH undergoing treatment compared to controls.

  From baseline to 6 months follow-up

• Analysis of association between methylation levels and treatment outcome defined as 1) reduction in headache days per month at 6 months and 12 months and 2) percent of cured vs. percent of relapsers after 12 months.

  At 6 and 12 months follow-up

Study Arms (5)

Detoxification and pharmacological prophylactic treatment

ACTIVE COMPARATOR

Group A: Two months detoxification program combined with pharmacological prophylactic treatment from start.

Other: Different well-known treatments

Pharmacological prophylactic treatment

ACTIVE COMPARATOR

Pharmacological prophylactic treatment from start without detoxification.

Other: Different well-known treatments

Detoxification

ACTIVE COMPARATOR

Two months detoxification program with postponed pharmacological prophylactic treatment after ended detoxification.

Other: Different well-known treatments

Control group 1: Episodic migraine

NO INTERVENTION

Control group 2: Healthy volunteers

NO INTERVENTION

Interventions

Different well-known treatments OTHER

Detoxification; Detoxification and pharmacological prophylactic treatment; Pharmacological prophylactic treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Prophylactics are allowed.
• Age ≥ 18 years old.
• Ability to fill out headache calendar.
• No previous medication overuse.
• No significant co-morbid pain, physical or psychiatric disorders.
• No addiction to alcohol or drug-abuse.
• No pregnancy, breastfeeding or planned pregnancy within the next 12 months.
• Criteria for Control group 2 - Healthy volunteers:

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (2)

• Carlsen LN, Hansen CS, Kogelman LJA, Werge TM, Ullum H, Bybjerg-Grauholm J, Hansen TF, Jensen RH. DNA-methylation and immunological response in medication overuse headache. Cephalalgia. 2023 Mar;43(3):3331024221147482. doi: 10.1177/03331024221147482.

  PMID: 36786322 DERIVED

• Carlsen LN, Munksgaard SB, Nielsen M, Engelstoft IMS, Westergaard ML, Bendtsen L, Jensen RH. Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1069-1078. doi: 10.1001/jamaneurol.2020.1179.

  PMID: 32453406 DERIVED

MeSH Terms

Conditions

Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD-student

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: October 24, 2016
• Primary Completion: July 2, 2019
• Study Completion: November 30, 2023
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

DK (1)