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

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ClinicalTrials.gov Identifier: NCT02101892
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Migraine Research Foundation
Information provided by (Responsible Party):
Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE March 18, 2014
First Posted Date  ICMJE April 2, 2014
Last Update Posted Date October 3, 2017
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2014)
the association between pre-treatment assessment parameter(s) and the reduction in frequency of migraine attacks by amitriptyline [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2014)
the association between pain-related psychological parameters and the reduction in migraine attacks by amitriptyline [ Time Frame: one year ]
The scores for Spielberger's anxiety state and trait questionnaire, and for pain catastrophising questionnaire will be used.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation
Official Title  ICMJE Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Migraine
  • Preventive Treatment
Intervention  ICMJE
  • Drug: Amitriptyline
    per os, daily, evening
    Other Name: Elatrol
  • Drug: placebo
    per os, daily, evening
    Other Name: sugar pills
Study Arms  ICMJE
  • Active Comparator: Amitriptyline
    Amitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days
    Intervention: Drug: placebo
  • Placebo Comparator: placebo
    sugar pills
    Intervention: Drug: Amitriptyline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2014)
60
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02101892
Other Study ID Numbers  ICMJE 0102-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Migraine Research Foundation
Investigators  ICMJE
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
PRS Account Rambam Health Care Campus
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP