Clinical trial NCT02101892: Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation
Official title: Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Preventive Treatment
Keywords: migraine
Amitriptyline
pain modulation
pain psychophysics
pain neurophysiology
preventive treatment
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Migraine Research Foundation
First posted: 2014-04-02
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment
timeFrame: one year
Secondary outcomes:
measure: predictive value of pain-related psychological parameters for benefit from amitriptyline treatment
timeFrame: one year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus and Technion Medical School
name: David Yarnitsky, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus and Technion Medical School
name: Yelena Granovsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nursing School, University of Haifa
name: Michal Granot, Professor
role: PRINCIPAL_INVESTIGATOR
References: