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Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation

NCT02101892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-10-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Amitriptyline

per os, daily, evening

DRUG

placebo

per os, daily, evening

Sponsors & Collaborators

  • Migraine Research Foundation

    collaborator OTHER

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • David Yarnitsky, MD, Professor · Rambam Health Care Campus and Technion Medical School

  • Yelena Granovsky, PhD · Rambam Health Care Campus and Technion Medical School

  • Michal Granot, Professor · Nursing School, University of Haifa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101892 on ClinicalTrials.gov