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

NCT01470339 | Completed DMC

• 1 other identifier: 0462-10-RMB.CTIL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

endogenous pain modulation; migraine; fMRI; duloxetine; preventive migraine treatment

Outcome Measures

Primary Outcomes (1)

• Distinguish between two endogenous pain modulation mechanisms

  2 year

Secondary Outcomes (1)

• To charcterize functional and structural neuroanatomical correlates of pain modulation profile and it's relevance for predicting the duloxetine efficacy in migraine

  3 years

Study Arms (2)

placebo

PLACEBO COMPARATOR

migraine patients to receive placebo treatment

Drug: duloxetine

duloxetine

ACTIVE COMPARATOR

migraine patients to receive duloxetine

Drug: duloxetine

Interventions

duloxetine DRUG

duloxetine 60mg once a day for 5 weeks

duloxetine; placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

MRI center

Haifa, Israel

Location

MeSH Terms

Conditions

Pain; Migraine Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Yarnitsky, professor

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head on Neurology Department

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

IL (1)