Skip to main content
OpenTrials
Completed

NCT Number: NCT01077375

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site 013, Sacramento, California, United States

Loading trial locations.

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug
  • Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
  • Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.

Milnacipran

Drug
  • Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
  • Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.

Other names: Savella

Primary outcomes

  1. Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)

    Time frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.

    The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.

Secondary outcomes

  1. Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score

    Time frame: Change from Baseline (Week 3) to Visit 5 (Week 13)

    The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Cypress Bioscience, Inc.

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 1, 2010
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.