NCT02993289UnknownNot Applicable
Is Detoxification Needed in Medication-overuse Headache?: A Randomized Controlled Trial of 3 Treatment Strategies
Danish Headache Center2 sites in 1 country115 target enrollmentStarted: October 24, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Danish Headache Center
- Enrollment
- 115
- Locations
- 2
- Primary Endpoint
- Reduction in headache days per month in group A and C compared to group B.
Study Overview
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:
- To compare three different treatment protocols in order to improve the therapy of MOH.
- To test several baseline variables for being potential predictors for good treatment outcome.
- To examine the role of epigenetics in MOH.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Reduction in headache days per month in group A and C compared to group B.
Time Frame: Six months follow-up
Secondary Outcomes
- 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)
- Changes in Headache Under-Response to Treatment (HURT)-score.(Two, 6 and 12 months follow-up)
- Drop-out rate.(One, 2, 4, 6, 9 and 12 months follow-up and 4 years)
- Changes in Hospital Anxiety and Depression Scale (HADS).(Six and 12 months follow-up)
- Changes in Quality of Life (QoL) score.(Six and 12 months follow-up)
- Changes in Severity of Dependence Score (SDS).(Six and 12 months follow-up)
- Changes in Perceived Stress Score (PSS).(Twelve months follow-up.)
- Patient's satisfaction questionnaire(Two, 6 and 12 months follow-up)
Investigators
Louise Carlsen
Medical doctor, PhD-student
Danish Headache Center
Study Sites (2)
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