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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02101892
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : October 3, 2017
Migraine Research Foundation
Information provided by (Responsible Party):
Rambam Health Care Campus

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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 Name: sugar pills

Placebo Comparator: placebo
sugar pills
Drug: Amitriptyline
per os, daily, evening
Other Name: Elatrol

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02101892

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Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Migraine Research Foundation
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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

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Responsible Party: Rambam Health Care Campus Identifier: NCT02101892    
Other Study ID Numbers: 0102-14
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Keywords provided by Rambam Health Care Campus:
pain modulation
pain psychophysics
pain neurophysiology
preventive treatment
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants