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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT02101892

Collaborator

Migraine Research Foundation (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Preventive Treatment	Drug: Amitriptyline Drug: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus
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