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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: duloxetine

• Registration Number: NCT01470339
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Study Start: 2011-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• healthy females
• migaine females
• ages 18-50
• for migraineurs: >4 attacks/month

Exclusion Criteria

• any migraine preventive treatment received during last 3 months or prior treatment with amytriptiline
• other chronic pain conditions
• psychiatric, other neurological diseases, language barrier or cognitive dysfunction
• Patients and controls will be asked to withdraw from any pain-relieving medications for 24 hours before the testing. The tests will be performed interictally atleast 2 days after the last attack.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	duloxetine	migraine patients to receive placebo treatment
duloxetine	duloxetine	migraine patients to receive duloxetine

Primary Outcome Measures

Name	Time	Method
Distinguish between two endogenous pain modulation mechanisms	2 year

Secondary Outcome Measures

Name	Time	Method
To charcterize functional and structural neuroanatomical correlates of pain modulation profile and it's relevance for predicting the duloxetine efficacy in migraine	3 years

Trial Locations

Locations (1)

MRI center; 🇮🇱 Haifa, Israel