Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population

Study Overview
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Brief Summary
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Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.

Official Title
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Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Savella


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients. Age 65 years or older. Fibromyalgia diagnosed according to ACR 1990 criteria. Pain Score ≥ 10 on Gracely scale at screening and baseline assessments. Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation. Exclusion Criteria: Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations. Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations. Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI. Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (> 450 msec). Uncontrolled narrow angle glaucoma. History of seizures. Use of MAO inhibitor drugs within the last 14 days. Abnormal baseline liver or renal function tests. Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol. Obstructive uropathy in males.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milnacipran<br>Drug | Drug: Savella<br>* milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older | Percent change in self-reported severity of pain (averaged Visual Analog Scale scores) over 12 weeks of treatment. Rate of occurrence of adverse events necessitating drug discontinuation | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effects of milnacipran on cognition | Change in functional activity (FIQ), perceived health (SF-36), and severity of pain (Gracely scale). Incidence and severity of treatment-emergent adverse events. Change in sleep quality and daytime sleepiness as measured by the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale. Change in other sleep/wake parameters(actigraphy measures). Change in cognitive test scores from baseline to the 12 week visit. Patient global impression of change score. | 14 months |