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Discontinuation Study of the Durability of Effect of Milnacipran 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:
NCT01014585
First received: November 13, 2009
Last updated: September 2, 2011
Last verified: September 2011

November 13, 2009
September 2, 2011
November 2009
May 2010   (final data collection date for primary outcome measure)
Time to Loss of Therapeutic Response (LTR) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment
Loss of therapeutic response (LTR), defined as a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the Investigator, an alternative treatment [ Time Frame: 12 weeks randomized treatment period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01014585 on ClinicalTrials.gov Archive Site
  • Time to Worsening in Patient Global Impression of Change (PGIC) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
    Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.
  • Time to Worsening in Multidimensional Assessment of Fatigue (MAF) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
    Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).
  • Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks randomized treatment period ] [ Designated as safety issue: No ]
  • Multidimensional Assessment of Fatigue (MAF) [ Time Frame: 12 weeks randomized treatment period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment

The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Placebo
    Placebo tablets administered orally twice daily
  • Drug: Milnacipran
    Milnacipran tablets administered orally twice daily
    Other Name: Savella ®
  • Placebo Comparator: 1
    Placebo tablets administered orally twice daily
    Intervention: Drug: Placebo
  • Experimental: 2
    Milnacipran tablets administered orally twice daily
    Intervention: Drug: Milnacipran
Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
Not Provided
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently participating in Study MLN-MD-06
  • Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

  • Significant risk of suicide
  • History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
  • Myocardial infarction and/or stroke within the prior 12 months
  • Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
  • Active liver disease
  • Severe renal impairment
  • Platelet and bleeding disorders
  • Female patients who are pregnant or breastfeeding
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014585
MLN-MD-27
No
Forest Laboratories
Forest Laboratories
Cypress Bioscience, Inc.
Study Director: Joel Trugman, MD Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc
Forest Laboratories
September 2011

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