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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470339
• Other study ID #: 0462-10-RMB.CTIL
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: September 16, 2015
• Start date: December 2011
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• duloxetine
duloxetine 60mg once a day for 5 weeks

Locations

Country	Name	City	State
Israel	MRI center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distinguish between two endogenous pain modulation mechanisms		2 year	No
Secondary	To charcterize functional and structural neuroanatomical correlates of pain modulation profile and it's relevance for predicting the duloxetine efficacy in migraine		3 years	No