Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia

Treatments: Drug: Milnacipran; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014585

MLN-MD-27

Details and patient eligibility

About

The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Enrollment: 340 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently participating in Study MLN-MD-06
• Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion criteria

• Significant risk of suicide
• History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
• Myocardial infarction and/or stroke within the prior 12 months
• Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
• Active liver disease
• Severe renal impairment
• Platelet and bleeding disorders
• Female patients who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo tablets administered orally twice daily

Treatment:

Drug: Placebo

2

Experimental group

Description:

Milnacipran tablets administered orally twice daily

Treatment:

Drug: Milnacipran