Clinical Trials Directory

Trials / Completed

CompletedNCT01470339

Improvement the Anti-migraine Treatment Efficacy by Tailoring the Drug to Individual's Pain Modulation Profile

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
Rambam Health Care Campus · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

* To delineate brain mechanisms that subserve endogenous analgesic (EA) in the healthy state. * To identify alterations in mechanisms supporting EA in chronic pain (migraine) and their therapeutic relevance.

Detailed description

The proposed research will use psychophysics and multiparametric MRI to (i) delineate the brain mechanisms that subserve and regulate endogenous analgesia (EA)in the healthy state and (ii) to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. In both healthy subjects and chronic pain patients, EA will be probed using the DNIC (diffuse noxious inhibitory controls) and offset analgesia paradigms. Functional MRI will examine activation of brainstem mechanisms important in EA, while both functional and structural connectivity analyses will assess the regulation of these brainstem mechanisms by cerebral cortical regions involved in attention and affect. One pathological painful condition, migraine, will be examined since it allows changes in EA associated with chronic pain to be investigated between episodes of pain. Finally, EA and EA associated structural and functional parameters will be used to predict the efficacy of one compound, amitriptyline, to treat migraine in individual patients. Taken together, the proposed research will provide substantial insights into basic mechanisms supporting and regulating EA and can provide a foundation for mechanism-based individualized choice of therapy that may benefit all chronic pain patients.

Conditions

Interventions

TypeNameDescription
DRUGduloxetineduloxetine 60mg once a day for 5 weeks

Timeline

Start date
2011-12-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2011-11-11
Last updated
2015-09-17

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01470339. Inclusion in this directory is not an endorsement.