Study of Milnacipran in Patients With Inadequate Response to Duloxetine 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

NCT01077375

MLN-MD-28

Details and patient eligibility

About

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Full description

• Two weeks Duloxetine 60 mg Open-Label Period
• Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
• One week Double-Blind Down-Taper Period

Enrollment: 107 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of fibromyalgia
• Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
• Duloxetine must have been prescribed for the treatment of Fibromyalgia
• Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
• At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

Exclusion criteria

• Suicidal risk
• History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
• Myocardial infarction and/or stroke within the prior 6 months
• Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)
• Substance abuse
• Pulmonary dysfunction
• Severe renal impairment
• Active cardiac disease
• Liver disease
• Uncontrolled narrow-angle glaucoma
• Autoimmune disease
• Cancer
• Inflammatory bowel disease
• Unstable endocrine disease
• Prostatic enlargement
• 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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107 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablets, twice a day, oral administration

Treatment:

Drug: Placebo

Milnacipran

Experimental group

Description:

Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Treatment:

Drug: Milnacipran