The Effect of Milnacipran in Patients With Fibromyalgia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-01-31

Brief Summary

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Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

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Detailed Description

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Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patients taking the drug Milnacipran

Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.

Group Type ACTIVE_COMPARATOR

Milnacipran

Intervention Type DRUG

Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.

Patients taking the placebo

Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.

Interventions

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Milnacipran

Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.

Intervention Type DRUG

Placebo

Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.

Intervention Type DRUG

Other Intervention Names

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Savella

Eligibility Criteria

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Inclusion Criteria

* Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
* 18 through 68 years of age

Exclusion Criteria

* Pregnant or trying to become pregnant
* Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
* Patients who do not indicate their pain levels as less than substantial despite their best care
* History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
* Presence of current depression as determined by psychiatric diagnostic interview
* Presence of brain lesion on MRI anatomical study

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No