Clinical trial NCT01077375: Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: Milnacipran
Duloxetine
Switch
Forest Research Institute
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Cypress Bioscience, Inc.
First posted: 2010-03-01
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

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

Primary outcomes:
measure: Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
timeFrame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.
Secondary outcomes:
measure: Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score
timeFrame: Change from Baseline (Week 3) to Visit 5 (Week 13)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Forest Investigative Site 013
state: California
city: Cromwell
country: United States
facility: Forest Investigative Site 022
state: Connecticut
city: Danbury
country: United States
facility: Forest Investigative Site 021
state: Connecticut
city: Delray Beach
country: United States
facility: Forest Investigative Site 007
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 008
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 009
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 016
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 019
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 006
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 024
state: Georgia
city: Evansville
country: United States
facility: Forest Investigative Site 015
state: Indiana
city: Worchester
country: United States
facility: Forest Investigative Site 005
state: Massachusetts
city: Jackson
country: United States
facility: Forest Investigative Site 010
state: Mississippi
city: St. Louis
country: United States
facility: Forest Investigative Site 025
state: Missouri
city: Willingboro
country: United States
facility: Forest Investigative Site 018
state: New Jersey
city: Syracuse
country: United States
facility: Forest Investigative Site 014
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 023
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site 002
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site 003
state: Ohio
city: Medford
country: United States
facility: Forest Investigative Site 001
state: Oregon
city: Mechanicsburg
country: United States
facility: Forest Investigative Site 020
state: Pennsylvania
city: Greer
country: United States
facility: Forest Investigative Site 011
state: South Carolina
city: Salt Lake City
country: United States
facility: Forest Investigative Site 004
state: Utah
city: Bellevue
country: United States
facility: Forest Investigative Site 017
state: Washington
city: Racine
country: United States
facility: Forest Investigative Site 026
state: Wisconsin
Study officials:
affiliation: Forest Research Institute Inc., A Subsidiary of Forest Laboratories
name: Allan Spera
role: STUDY_DIRECTOR
References: