Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

NCT ID: NCT00793520

Last Updated: 2010-07-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Brief Summary

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The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.

Group Type EXPERIMENTAL

Milnacipran

Intervention Type DRUG

Twice daily oral administration of Milnacipran for 5 weeks.

Placebo

Intervention Type DRUG

Twice daily oral administration of placebo for 5 weeks.

2

Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Twice daily oral administration of placebo for 5 weeks.

Milnacipran

Intervention Type DRUG

Twice daily oral administration of Milnacipran for 5 weeks.

Interventions

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Milnacipran

Twice daily oral administration of Milnacipran for 5 weeks.

Intervention Type DRUG

Placebo

Twice daily oral administration of placebo for 5 weeks.

Intervention Type DRUG

Placebo

Twice daily oral administration of placebo for 5 weeks.

Intervention Type DRUG

Milnacipran

Twice daily oral administration of Milnacipran for 5 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
* Visual analog pain score between 40 and 90 mm
* Right-hand dominance

Exclusion Criteria

* Suicidal risk
* Substance Abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Autoimmune disease
* Uncontrolled narrow-angle glaucoma
* Active liver disease
* Cancer
* Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue
* Unstable endocrine disease
* Prostatic enlargement
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Forest Research Insititute

Principal Investigators

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Allan Spera

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories Inc

Locations

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Forest Investigative Site

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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MLN-MD-16

Identifier Type: -

Identifier Source: org_study_id

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