Migraine, Preventive Treatment
Conditions
Keywords
migraine, Amitriptyline, pain modulation, pain psychophysics, pain neurophysiology, preventive treatment
Brief summary
A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only \ 50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy.
Interventions
DRUGAmitriptyline
per os, daily, evening
DRUGplacebo
per os, daily, evening
Sponsors
Migraine Research Foundation
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age \>18 * premenopausal * meeting the international headache society criteria for migraine * having \>4 attacks or days of migraine/month
Exclusion criteria
* baseline month diary indicating lower frequency of migraine * chronic migraine (\>15 days of headache per month) * use of migraine preventive treatment during previous 3 month * language barrier or cognitive dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment | one year | ANCOVA will be utilized, based on factors treatment (amitriptyline or placebo), conditioned pain modulation capabilities (responder or non-responder), their interaction, a number of covariates, to predict reduction attacks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| predictive value of pain-related psychological parameters for benefit from amitriptyline treatment | one year | The scores for Spielberger's anxiety state and trait questionnaire, and for pain catastrophising questionnaire will be used. |
Countries
Israel
Outcome results
None listed