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

This study has been completed.
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01077375
First received: February 25, 2010
Last updated: December 21, 2011
Last verified: December 2011

February 25, 2010
December 21, 2011
February 2010
December 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Patient Global Impression of Change (PGIC) [ Time Frame: Assessed 6 and 10 weeks (or early termination) after randomization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01077375 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
Visual Analog Scale (VAS) 1-week Pain Recall Score [ Time Frame: Assessed at Screening, Baseline, and 6 and 10 weeks (or early termination) after randomization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
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

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.

  • 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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Placebo
    • 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.
  • Drug: Milnacipran
    • 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 Name: Savella
  • Placebo Comparator: Placebo
    Placebo tablets, twice a day, oral administration
    Intervention: Drug: Placebo
  • Experimental: Milnacipran
    Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
    Intervention: Drug: Milnacipran
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
January 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01077375
MLN-MD-28
No
Forest Laboratories
Forest Laboratories
Cypress Bioscience, Inc.
Study Director: Allan Spera Forest Research Institute Inc., A Subsidiary of Forest Laboratories
Forest Laboratories
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP