Is Detoxification Needed in Medication-overuse Headache? (DEFINE3)

Danish Headache Center

Status: Unknown

Conditions: Medication Overuse Headache

Treatments: Other: Different well-known treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT02993289

H-16029763

Details and patient eligibility

About

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.

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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115 participants in 5 patient groups

Detoxification and pharmacological prophylactic treatment

Active Comparator group

Description:

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

Treatment:

Other: Different well-known treatments

Pharmacological prophylactic treatment

Active Comparator group

Description:

Pharmacological prophylactic treatment from start without detoxification.

Treatment:

Other: Different well-known treatments

Detoxification

Active Comparator group

Description:

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

Treatment:

Other: Different well-known treatments

Control group 1: Episodic migraine

No Intervention group

Control group 2: Healthy volunteers

No Intervention group