NCT02101892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 3, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

March 18, 2014

Last Update Submit

October 1, 2017

Conditions

MigrainePreventive Treatment

Keywords

migraineAmitriptylinepain modulationpain psychophysicspain neurophysiologypreventive treatment

Outcome Measures

Primary Outcomes (1)

  • predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment

    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.

    one year

Secondary Outcomes (1)

  • predictive value of pain-related psychological parameters for benefit from amitriptyline treatment

    one year

Study Arms (2)

Amitriptyline

ACTIVE COMPARATOR

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

Drug: placebo

placebo

PLACEBO COMPARATOR

sugar pills

Drug: Amitriptyline

Interventions

AmitriptylineDRUG

per os, daily, evening

Also known as: Elatrol
placebo
placeboDRUG

per os, daily, evening

Also known as: sugar pills
Amitriptyline

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18
  • premenopausal
  • meeting the international headache society criteria for migraine
  • having \>4 attacks or days of migraine/month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 2, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 3, 2017

Record last verified: 2017-10

Locations

IL(1)