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

NCT ID: NCT02101892

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Preventive Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Amitriptyline

Amitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

per os, daily, evening

placebo

sugar pills

Group Type PLACEBO_COMPARATOR

Amitriptyline

Intervention Type DRUG

per os, daily, evening

Interventions

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Amitriptyline

per os, daily, evening

Intervention Type DRUG

placebo

per os, daily, evening

Intervention Type DRUG

Other Intervention Names

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Elatrol sugar pills

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Migraine Research Foundation

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Yarnitsky, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus and Technion Medical School

Yelena Granovsky, PhD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus and Technion Medical School

Michal Granot, Professor

Role: PRINCIPAL_INVESTIGATOR

Nursing School, University of Haifa

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0102-14

Identifier Type: -

Identifier Source: org_study_id