Is Detoxification Needed in Medication-overuse Headache?

Medication Overuse Headache Clinical Trial

— DEFINE3  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02993289
• Other study ID #: H-16029763
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 24, 2016
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: November 30, 2023
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients with medication-overuse headache:

Inclusion Criteria:

• 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.

• 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:

•= 2 days with headache in the past month at time of inclusion.

• Days with analgesics / month = 6 at time of inclusion.

• Age = 18 years old.

• 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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Intervention

Other:
• Different well-known treatments

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in DNA-profile between patients with MOH and controlgroups.		Baseline
Other	Difference in methylation levels and RNA sequence analysis in patients with MOH undergoing treatment compared to controls.		From baseline to 6 months follow-up
Other	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
Primary	Reduction in headache days per month in group A and C compared to group B.		Six months follow-up
Secondary	Reduction in headache days per month	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Two and 12 months follow-up and 4 years
Secondary	Reduction in days/month with use of analgesics and/or migraine medication.	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Two, 6 and 12 months follow-up and 4 years
Secondary	Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%).	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Two, 6 and 12 months follow-up and 4 years
Secondary	Reduction in headache intensity.	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).; This outcome will be presented as 1) Total headache intensity per month, and as 2) Visual Analogue Scale (VAS).	Two, 6 and 12 months follow-up and 4 years
Secondary	Descriptive report of self-reported adverse effects of treatments.	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Two, 6 and 12 months follow-up
Secondary	Changes in Headache Under-Response to Treatment (HURT)-score.	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Two, 6 and 12 months follow-up
Secondary	Drop-out rate.		One, 2, 4, 6, 9 and 12 months follow-up and 4 years
Secondary	Changes in Hospital Anxiety and Depression Scale (HADS).	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Six and 12 months follow-up
Secondary	Changes in Quality of Life (QoL) score.	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Six and 12 months follow-up
Secondary	Changes in Severity of Dependence Score (SDS).	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Six and 12 months follow-up
Secondary	Changes in Perceived Stress Score (PSS).	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Twelve months follow-up.
Secondary	Patient's satisfaction questionnaire	Group A and C versus group B.; Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).; Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).	Two, 6 and 12 months follow-up