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

October 1, 2017 updated by: Rambam Health Care Campus

Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Amitriptyline
Amitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days
Drug: placebo
per os, daily, evening
Other Names:
  • sugar pills
PLACEBO_COMPARATOR: placebo
sugar pills
Drug: Amitriptyline
per os, daily, evening
Other Names:
  • Elatrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictive value of pain-related psychological parameters for benefit from amitriptyline treatment
Time Frame: one year
The scores for Spielberger's anxiety state and trait questionnaire, and for pain catastrophising questionnaire will be used.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Migraine Research Foundation

Investigators

  • Principal Investigator: David Yarnitsky, MD, Professor, Rambam Health Care Campus and Technion Medical School
  • Principal Investigator: Yelena Granovsky, PhD, Rambam Health Care Campus and Technion Medical School
  • Principal Investigator: Michal Granot, Professor, Nursing School, University of Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 30, 2014

First Posted (ESTIMATE)

April 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 1, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0102-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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