Phase 4 Completed N=107 Randomized Quadruple-blind Treatment

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Fibromyalgia

Source: ClinicalTrials.gov NCT01077375 ↗

Enrolled (actual)

107

Serious AEs

1.9%

Results posted

Jan 2012

Primary outcomePrimary: Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) — 5; 26 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)	5; 26	—
SECONDARY Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score	-1.3; -12.3	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01077375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.