NCT01470352

Brief Summary

To delineate brain mechanisms that subserve EA in the healthy state and to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. Individuals with migraine will be examined between episodes in order to assess basal alterations in the efficiency of spatial and temporal filtering of noxious information. This population provides the unique opportunity to examine such processes without confounds arising from ongoing pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 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

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

November 16, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

6 years

First QC Date

November 9, 2011

Last Update Submit

March 26, 2019

Conditions

Migraine

Keywords

migrainepainCPMoffset analgesiafMRI

Outcome Measures

Primary Outcomes (1)

  • Therapeutic response to the analgesic drugs

    The level of pain relief

    2 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: DoluxetineDrug: Placebo

treatment

ACTIVE COMPARATOR

Duloxetine will be given in a daily dose of 30 mg for 5 weeks

Drug: DoluxetineDrug: Placebo

Interventions

DoluxetineDRUG

30 mg/d

Also known as: duloxetine
Placebotreatment
PlaceboDRUG

suger pill 30mg/d

Also known as: sugar
Placebotreatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients diagnosed with migraine based on the International Headache Society (IHS) criteria 1 that have \>4 attacks/month, both with and without aura

You may not qualify if:

  • patients receiving any migraine preventive treatment during last 3 months or prior treatment with amytriptiline
  • other chronic pain conditions
  • psychiatric, other neurological diseases, 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 DisordersPain

Interventions

Duloxetine HydrochlorideSugars

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Neurology Department

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

November 16, 2011

Primary Completion

November 6, 2017

Study Completion

November 6, 2017

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

IL(1)