Is Detoxification Needed in Medication-overuse Headache?
NCT ID: NCT02993289
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
115 participants
INTERVENTIONAL
2016-10-24
2023-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Detoxification and pharmacological prophylactic treatment
Group A: Two months detoxification program combined with pharmacological prophylactic treatment from start.
Different well-known treatments
Pharmacological prophylactic treatment
Pharmacological prophylactic treatment from start without detoxification.
Different well-known treatments
Detoxification
Two months detoxification program with postponed pharmacological prophylactic treatment after ended detoxification.
Different well-known treatments
Control group 1: Episodic migraine
No interventions assigned to this group
Control group 2: Healthy volunteers
No interventions assigned to this group
Interventions
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Different well-known treatments
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Louise Carlsen
Medical doctor, PhD-student
Locations
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Danish Headache Center
Glostrup Municipality, Copenhagen, Denmark
Countries
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References
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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.
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.
Other Identifiers
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H-16029763
Identifier Type: -
Identifier Source: org_study_id
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