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| Name | Class |
|---|---|
| Cypress Bioscience, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablets, twice a day, oral administration |
|
| Milnacipran | Experimental | Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) | 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. | Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score | The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain). | Change from Baseline (Week 3) to Visit 5 (Week 13) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan Spera | Forest Research Institute Inc., A Subsidiary of Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 013 | Sacramento | California | 95825 | United States | ||
| Forest Investigative Site 022 |
All participants were given an open-label treatment of duloxetine 60 mg once daily for a two week period before randomization.
Patients randomized to placebo received 1 week of duloxetine 30 mg to effect a duloxetine down-taper. Patients randomized to milnacipran received 1 week of placebo capsules to maintain the blind.
Recruitment occurred over an 8 month period from February 2010 to September 2010 at 25 study centers in the United States. Last patient last visit occurred on December 22nd, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration. |
| FG001 | Milnacipran | Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Milnacipran | Drug |
|
|
|
| Cromwell |
| Connecticut |
| 06416 |
| United States |
| Forest Investigative Site 021 | Danbury | Connecticut | 06810 | United States |
| Forest Investigative Site 007 | Delray Beach | Florida | 33484 | United States |
| Forest Investigative Site 008 | Ocala | Florida | 34471 | United States |
| Forest Investigative Site 009 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 016 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 012 | St. Petersburg | Florida | 33709 | United States |
| Forest Investigative Site 019 | Tampa | Florida | 33614 | United States |
| Forest Investigative Site 006 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 024 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 015 | Evansville | Indiana | 47713 | United States |
| Forest Investigative Site 005 | Worchester | Massachusetts | 01610 | United States |
| Forest Investigative Site 010 | Jackson | Mississippi | 39202 | United States |
| Forest Investigative Site 025 | St Louis | Missouri | 63141 | United States |
| Forest Investigative Site 018 | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site 014 | Syracuse | New York | 13210 | United States |
| Forest Investigative Site 023 | Charlotte | North Carolina | 28209 | United States |
| Forest Investigative Site 002 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 003 | Cleveland | Ohio | 44122 | United States |
| Forest Investigative Site 001 | Medford | Oregon | 97504 | United States |
| Forest Investigative Site 020 | Mechanicsburg | Pennsylvania | 17055 | United States |
| Forest Investigative Site 011 | Greer | South Carolina | 29651 | United States |
| Forest Investigative Site 004 | Salt Lake City | Utah | 84102 | United States |
| Forest Investigative Site 017 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 026 | Racine | Wisconsin | 53406 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration. |
| BG001 | Milnacipran | Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration. One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population. |
| BG002 | 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 | participants |
| ||||||||||||||||
| 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 | Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) | 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. | ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing. | Posted | Number | participants | Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. |
|
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| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score | The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain). | ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing. | Posted | Mean | Standard Deviation | Units on a scale | Change from Baseline (Week 3) to Visit 5 (Week 13) |
|
Adverse event data was collected over a nearly 10 month period from March 4th, 2010 through December 22, 2010.
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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 | Placebo | Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration. | 0 | 21 | 16 | 21 | ||
| EG001 | Milnacipran | Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration. One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population. Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5). | 2 | 85 | 63 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be 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 | |
|---|---|---|---|---|
| Allan Spera, Director, Clinical Development | Forest Research Institute | (201) 427-8399 | Allan.Spera@frx.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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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 to 70 |
|
| Male |
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| Units |
|---|
| Counts |
|---|
| Participants |
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