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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Milnacipran

Drug

Group Type EXPERIMENTAL

Savella

Intervention Type DRUG

milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)

Interventions

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Savella

milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)

Intervention Type DRUG

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No