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| Name | Class |
|---|---|
| Cypress Bioscience, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo tablets administered orally twice daily |
|
| 2 | Experimental | Milnacipran tablets administered orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablets administered orally twice daily |
| |
| Milnacipran |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Loss of Therapeutic Response (LTR) | 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 | From baseline Visit 3 (week 5) to Visit 7 (week 17) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Worsening in Patient Global Impression of Change (PGIC) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Trugman, MD | Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 062 | Birmingham | Alabama | 35205 | United States | ||
| Forest Investigative Site 065 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23953493 | Derived | 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. |
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Upon completion of a long term milnacipran open label study MLN-MD-06, patients were enrolled in the current study MLN-MD-27 (NCT01014585), and received open label treatment with milnacipran for four weeks prior to randomization.
Recruitment period was from November 2009 through February 2010 at 58 centers in the United States with the last patient visit occurring on June 7, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Responders: Placebo (Milnacipran Withdrawn) | The Randomized Population for Responders |
| FG001 | Responders: Milnacipran (Milnacipran Continued) | The Randomized Population for Responders |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Milnacipran tablets administered orally twice daily |
|
|
| From baseline Visit 3 (week 5) to Visit 7 (week 17) |
| Time to Worsening in Multidimensional Assessment of Fatigue (MAF) | 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). | From baseline Visit 3 (week 5) to Visit 7 (week 17) |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Forest Investigative Site 012 | Tucson | Arizona | 85704 | United States |
| Forest Investigative Site 007 | Fresno | California | 93710 | United States |
| Forest Investigative Site 032 | Pismo Beach | California | 93449 | United States |
| Forest Investigative Site 025 | Sacramento | California | 95825 | United States |
| Forest Investigative Site 019 | San Diego | California | 92108 | United States |
| Forest Investigative Site 057 | Santa Ana | California | 92705 | United States |
| Forest Investigative Site 039 | Vista | California | 92083 | United States |
| Forest Investigative Site 050 | Cromwell | Connecticut | 06416 | United States |
| Forest Investigative Site 049 | Danbury | Connecticut | 06810 | United States |
| Forest Investigative Site 055 | Stamford | Connecticut | 06905 | United States |
| Forest Investigative Site 011 | Delray Beach | Florida | 33484 | United States |
| Forest Investigative Site 013 | Ocala | Florida | 34471 | United States |
| Forest Investigative Site 016 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 043 | Palm Harbor | Florida | 34684 | United States |
| Forest Investigative Site 060 | Pembroke Pines | Florida | 33029 | United States |
| Forest Investigative Site 066 | Atlanta | Georgia | 30319 | United States |
| Forest Investigative Site 009 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 026 | Honolulu | Hawaii | 96814 | United States |
| Forest Investigative Site 056 | Libertyville | Illinois | 60048 | United States |
| Forest Investigative Site 038 | Peoria | Illinois | 61614 | United States |
| Forest Investigative Site 031 | Evansville | Indiana | 47713 | United States |
| Forest Investigative Site 064 | Frederick | Maryland | 21702 | United States |
| Forest Investigative Site 030 | Newton | Massachusetts | 02462 | United States |
| Forest Investigative Site 048 | North Dartmouth | Massachusetts | 02747 | United States |
| Forest Investigative Site 017 | Springfield | Massachusetts | 01103 | United States |
| Forest Investigative Site 008 | Worcester | Massachusetts | 01610 | United States |
| Forest Investigative Site 061 | Kalamazoo | Michigan | 49009 | United States |
| Forest Investigative Site 020 | Jackson | Mississippi | 39202 | United States |
| Forest Investigative Site 004 | St Louis | Missouri | 63141 | United States |
| Forest Investigative Site 033 | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site 040 | Albuquerque | New Mexico | 87108 | United States |
| Forest Investigative Site 035 | Great Neck | New York | 11021 | United States |
| Forest Investigative Site 014 | Rochester | New York | 14618 | United States |
| Forest Investigative Site 027 | Syracuse | New York | 13210 | United States |
| Forest Investigative Site 054 | Charlotte | North Carolina | 28209 | United States |
| Forest Investigative Site 018 | Greensboro | North Carolina | 27408 | United States |
| Forest Investigative Site 002 | Greenville | North Carolina | 27834 | United States |
| Forest Investigative Site 024 | Salisbury | North Carolina | 28144 | United States |
| Forest Investigative Site 042 | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site 003 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 005 | Cleveland | Ohio | 44122 | United States |
| Forest Investigative Site 059 | Columbus | Ohio | 43212 | United States |
| Forest Investigative Site 044 | Eugene | Oregon | 97401 | United States |
| Forest Investigative Site 010 | Eugene | Oregon | 97404 | United States |
| Forest Investigative Site 001 | Medford | Oregon | 97504 | United States |
| Forest Investigative Site 052 | Medford | Oregon | 97504 | United States |
| Forest Investigative Site 041 | Portland | Oregon | 97205 | United States |
| Forest Investigative Site 051 | Duncansville | Pennsylvania | 16635 | United States |
| Forest Investigative Site 046 | Mechanicsburg | Pennsylvania | 17055 | United States |
| Forest Investigative Site 028 | Anderson | South Carolina | 29621 | United States |
| Forest Investigative Site 021 | Greer | South Carolina | 29651 | United States |
| Forest Investigative Site 006 | Salt Lake City | Utah | 84102 | United States |
| Forest Investigative Site 015 | Chesapeake | Virginia | 23320 | United States |
| Forest Investigative Site 047 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site 036 | Wenatchee | Washington | 98801 | United States |
| Forest Investigative Site 063 | Racine | Wisconsin | 53406 | United States |
| FG002 | Non-Responders: Placebo (Milnacipran Withdrawn) | The Randomized Population for Non-Responders |
| FG003 | Non-Responders: Milnacipran (Milnacipran Continued) | The Randomized Population for Non-Responders |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Responders: Placebo (Milnacipran Withdrawn) | Safety Population for Responders: placebo treatment assignment One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population. |
| BG001 | Responders: Milnacipran (Milnacipran Continued) | Safety Population for Responders: milnacipran treatment assignment |
| BG002 | Non-Responders: Placebo (Milnacipran Withdrawn) | Safety Population for Non-Responders: placebo treatment assignment |
| BG003 | Non-Responders: Milnacipran (Milnacipran Continued) | Safety Population for Non-Responders: milnacipran treatment assignment One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Loss of Therapeutic Response (LTR) | 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 | The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population. | Posted | Median | 95% Confidence Interval | Days | From baseline Visit 3 (week 5) to Visit 7 (week 17) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Worsening in Patient Global Impression of Change (PGIC) | 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. | The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population. | Posted | Median | 95% Confidence Interval | Days | From baseline Visit 3 (week 5) to Visit 7 (week 17) |
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| Secondary | Time to Worsening in Multidimensional Assessment of Fatigue (MAF) | 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). | The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population. | Posted | Median | 95% Confidence Interval | Days | From baseline Visit 3 (week 5) to Visit 7 (week 17) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Responders: Placebo (Milnacipran Withdrawn) | Safety Population for Responders: placebo treatment assignment One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population. | 0 | 50 | 8 | 50 | ||
| EG001 | Responders: Milnacipran (Milnacipran Continued) | Safety Population for Responders: milnacipran treatment assignment | 1 | 100 | 6 | 100 | ||
| EG002 | Non-Responders: Placebo (Milnacipran Withdrawn) | Safety Population for Non-Responders: placebo treatment assignment | 1 | 60 | 10 | 60 | ||
| EG003 | Non-Responders: Milnacipran (Milnacipran Continued) | Safety Population for Non-Responders: milnacipran treatment assignment One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population. | 3 | 128 | 30 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
All data generated in this study is the property of Forest Research Institute, Inc. An integrated clinical and statistical report was prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Trugman, MD | Forest Research Institute, Inc., a subsidiary of Forest Laboratories, Inc. | 201-427-8681 | joel.trugman@frx.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| >=60 years |
|
| Male |
|
| Days until LTR at the 25th percentile |
| 18 |
| 95 |
| No |
| Superiority or Other |
| Days until LTR at the 25th percentile | 45 | 95 | No | Superiority or Other |
| OG002 | Non-Responders: Placebo (Milnacipran Withdrawn) | Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day. |
| OG003 | Non-Responders: Milnacipran (Milnacipran Continued) | Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day. |
|
|
|
| OG002 | Non-Responders: Placebo (Milnacipran Withdrawn) | Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day. |
| OG003 | Non-Responders: Milnacipran (Milnacipran Continued) | Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day. |
|
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