Chronification and reversibility in migraine (CHARM)

Phase 4

Completed

Conditions: Chronic Migraine
Medication Overuse Headache
10019231

Registration Number: NL-OMON39808

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

Patients suffering from chronic migraine according to the ICHD-II criteria for chronic migraine as mentioned below, with medication overuse according to the ICHD-II criteria as mentioned below.;General criteria:
• Age =/> 18 years;Specific criteria chronic migraine group:
• Headache (tension-type and/or migraine) on =/> 15 days per month for at least 3 months
• Occuring in a patient who has at least five attacks fulfilling criteria for migraine without aura
• On =/> 8 days/month for =/> 3 months headache has fulfilled criteria for pain associated symptoms of migraine without aura
• Headache has at least two of a-d:
a. Unilateral location
b. Pulsating quality
c. Moderate or severe pain intensity
d. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs)
o AND at least one of a or b:
a. Nausea and/or vomiting
b. Photophobia and phonophobia
OR Headache is treated and relieved by triptan(s) or ergot before expecting development of headache with above mentioned criteria
• No medication overuse and not attributed to another causative disorder;According to the last criterium there will be an exception in this trial, since we are looking for patients with chronic migraine and medication overuse. Medication overuse will, according to the ICHD-II criteria be defined as follows:;Criteria medication overuse headache
• Headache present on =/> 15 days per month
• Regular overuse for =/> 3 months of one or more acute/symptomatic treatment drugs as defined under subforms:
1. Ergotamine, triptans, opioids, or combination analgesics on =/> 10 days per month on a regular basis for =/> 3 months
2. Simple analgesics or any combination of ergotamine, triptans, analgesics, or opioids on =/> 15 days per month on a regular basis for =/> 3 months without overuse of any single class alone
• Headache has developed or markedly worsened during medication overuse;(in short, we will combine definitions of Chronic Migraine and Medication Overuse Headache, since MoH can per definition not coëxist with chronic migraine. Also MoH can not be proven until after successful withdrawal)
(Zie protocol appendix 2: inclusion and exclusion criteria)

Exclusion Criteria

General exclusion criteria:
- Age under 18 years
- Other neurological, oncologic or psychiatric disease, other than the specific types described in the inclusion criteria
- Any cognitive disorders and/or behavioral problems which in the opinion of the clinician may interfere with the study
- Current abuse of softdrugs or harddrugs or history of abuse of softdrugs or harddrugs in the past 12 months as defined in the DSM-IV criteria under 'Substance abuse' or 'Substance dependence'.(abuse of amphetamines, cocaine, heroine, cannabis)
- use of non-triptan or non-analgesic acute anti-headache medication (ergots, opioids, barbiturates).
- pregnancy, planned pregnancy, current nursing.
- women of childbearing potential not using contraception
- Inability to complete the (electronic) diary in a sensible and accurate manner
- Enrolment in other studies that in the opinion of the clinician may confound the results of this study;Botox-specific exclusion criteria:
- Any neuromuscular disorder
- pregnancy, planned pregnancy, current nursing.
- Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
- Infection at the proposed injection site(s)
- Marcoumar;MRI-specific exclusion criteria
- Pregnancy, planned pregnancy, current nursing.
- Implanted pacemaker or implanted defibrillator-device
- Surgical clips in cerebral vasculature
- Metal debris in the eyes
- Non-removable hearing-aid
- Non-removable neuro-stimulator
- Hydrocephalus-pump
- Denture with magnetic fixation
- Copper-containing Intra-uterine Device
- History of surgery in which ferrous implants were implanted
- Weight over 160kg.;(See protocol appendix 2: inclusion and exclusion criteria)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures:<br /><br>The primary outcome measure is the relative reduction in headache days per<br /><br>month, in a comparison of the last month of withdrawal (month 3) with the<br /><br>baseline period (month -1). A headache day is defined as a day on which there<br /><br>is at least one period of * 4 hours of continuous headache. The relative<br /><br>reduction will be measured in the Btx and placebo groups and will be adjusted<br /><br>using multivariate analysis for depression scores at baseline and support by<br /><br>the headache nurse. As an alternative primary outcome measure, we will measure<br /><br>quality of life during the withdrawal trial. This will be measured by the<br /><br>Sumscore on the SF-36 questionnaire at timepoint 0, 1, 2 and 3.</p><br>

Secondary Outcome Measures