Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
This study has been completed.
Sponsor:
Forest Laboratories
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: Placebo Drug: Milnacipran |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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).
| Enrollment: | 340 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo tablets administered orally twice daily
|
Drug: Placebo
Placebo tablets administered orally twice daily
|
|
Experimental: 2
Milnacipran tablets administered orally twice daily
|
Drug: Milnacipran
Milnacipran tablets administered orally twice daily
Other Name: Savella ®
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014585
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| United States, Alabama | |
| Forest Investigative Site 062 | |
| Birmingham, Alabama, United States, 35205 | |
| Forest Investigative Site 065 | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Forest Investigative Site 012 | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Forest Investigative Site 007 | |
| Fresno, California, United States, 93710 | |
| Forest Investigative Site 032 | |
| Pismo Beach, California, United States, 93449 | |
| Forest Investigative Site 025 | |
| Sacramento, California, United States, 95825 | |
| Forest Investigative Site 019 | |
| San Diego, California, United States, 92108 | |
| Forest Investigative Site 057 | |
| Santa Ana, California, United States, 92705 | |
| Forest Investigative Site 039 | |
| Vista, California, United States, 92083 | |
| United States, Connecticut | |
| Forest Investigative Site 050 | |
| Cromwell, Connecticut, United States, 06416 | |
| Forest Investigative Site 049 | |
| Danbury, Connecticut, United States, 06810 | |
| Forest Investigative Site 055 | |
| Stamford, Connecticut, United States, 06905 | |
| United States, Florida | |
| Forest Investigative Site 011 | |
| Delray Beach, Florida, United States, 33484 | |
| Forest Investigative Site 013 | |
| Ocala, Florida, United States, 34471 | |
| Forest Investigative Site 016 | |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 043 | |
| Palm Harbor, Florida, United States, 34684 | |
| Forest Investigative Site 060 | |
| Pembroke Pines, Florida, United States, 33029 | |
| United States, Georgia | |
| Forest Investigative Site 009 | |
| Atlanta, Georgia, United States, 30328 | |
| Forest Investigative Site 066 | |
| Atlanta, Georgia, United States, 30319 | |
| United States, Hawaii | |
| Forest Investigative Site 026 | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Illinois | |
| Forest Investigative Site 056 | |
| Libertyville, Illinois, United States, 60048 | |
| Forest Investigative Site 038 | |
| Peoria, Illinois, United States, 61614 | |
| United States, Indiana | |
| Forest Investigative Site 031 | |
| Evansville, Indiana, United States, 47713 | |
| United States, Maryland | |
| Forest Investigative Site 064 | |
| Frederick, Maryland, United States, 21702 | |
| United States, Massachusetts | |
| Forest Investigative Site 048 | |
| N. Dartmouth, Massachusetts, United States, 02747 | |
| Forest Investigative Site 030 | |
| Newton, Massachusetts, United States, 02462 | |
| Forest Investigative Site 017 | |
| Springfield, Massachusetts, United States, 01103 | |
| Forest Investigative Site 008 | |
| Worcester, Massachusetts, United States, 01610 | |
| United States, Michigan | |
| Forest Investigative Site 061 | |
| Kalamazoo, Michigan, United States, 49009 | |
| United States, Mississippi | |
| Forest Investigative Site 020 | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Forest Investigative Site 004 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Forest Investigative Site 033 | |
| Cherry Hill, New Jersey, United States, 08002 | |
| United States, New Mexico | |
| Forest Investigative Site 040 | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Forest Investigative Site 035 | |
| Great Neck, New York, United States, 11021 | |
| Forest Investigative Site 014 | |
| Rochester, New York, United States, 14618 | |
| Forest Investigative Site 027 | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Forest Investigative Site 054 | |
| Charlotte, North Carolina, United States, 28209 | |
| Forest Investigative Site 018 | |
| Greensboro, North Carolina, United States, 27408 | |
| Forest Investigative Site 002 | |
| Greenville, North Carolina, United States, 27834 | |
| Forest Investigative Site 024 | |
| Salisbury, North Carolina, United States, 28144 | |
| Forest Investigative Site 042 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Forest Investigative Site 003 | |
| Cincinnati, Ohio, United States, 45219 | |
| Forest Investigative Site 005 | |
| Cleveland, Ohio, United States, 44122 | |
| Forest Investigative Site 059 | |
| Columbus, Ohio, United States, 43212 | |
| United States, Oregon | |
| Forest Investigative Site 044 | |
| Eugene, Oregon, United States, 97401 | |
| Forest Investigative Site 010 | |
| Eugene, Oregon, United States, 97404 | |
| Forest Investigative Site 001 | |
| Medford, Oregon, United States, 97504 | |
| Forest Investigative Site 052 | |
| Medford, Oregon, United States, 97504 | |
| Forest Investigative Site 041 | |
| Portland, Oregon, United States, 97205 | |
| United States, Pennsylvania | |
| Forest Investigative Site 051 | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Forest Investigative Site 046 | |
| Mechanicsburg, Pennsylvania, United States, 17055 | |
| United States, South Carolina | |
| Forest Investigative Site 028 | |
| Anderson, South Carolina, United States, 29621 | |
| Forest Investigative Site 021 | |
| Greer, South Carolina, United States, 29651 | |
| United States, Utah | |
| Forest Investigative Site 006 | |
| Salt Lake City, Utah, United States, 84102 | |
| United States, Virginia | |
| Forest Investigative Site 015 | |
| Chesapeake, Virginia, United States, 23320 | |
| United States, Washington | |
| Forest Investigative Site 047 | |
| Seattle, Washington, United States, 98104 | |
| Forest Investigative Site 036 | |
| Wenatchee, Washington, United States, 98801 | |
| United States, Wisconsin | |
| Forest Investigative Site 063 | |
| Racine, Wisconsin, United States, 53406 | |
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Investigators
| Study Director: | Joel Trugman, MD | Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01014585 History of Changes |
| Other Study ID Numbers: | MLN-MD-27 |
| Study First Received: | November 13, 2009 |
| Results First Received: | June 7, 2011 |
| Last Updated: | September 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Forest Laboratories:
|
Milnacipran Pain Durability of Effect Loss of Therapeutic Response |
Fatigue Forest Research Institute Savella ® |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 22, 2013