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OpenTrials
Completed

NCT Number: NCT02101892

Prediction of Migraine Prevention Efficacy Based on Individual's 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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amitriptyline

Drug

per os, daily, evening

Other names: Elatrol

Placebo

Drug

per os, daily, evening

Other names: sugar pills

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Migraine Research Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2014
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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