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| Name | Class |
|---|---|
| Cypress Bioscience, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milnacipran | Experimental | oral administration, twice daily dosing |
|
| Placebo | Placebo Comparator | oral administration, twice daily dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milnacipran | Drug | Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study. Oral administration, twice daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo. | During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances | Change from Visit 7 (Week 8) to Visit 10 (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Severity (PGIS) | The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill | Change from Visit 7 (Week 8) to Visit 10 (Week 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia M D'Astoli, LPN | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 040 | Birmingham | Alabama | 35205 | United States | ||
| Forest Investigative Site 068 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26112278 | Derived | Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9. |
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116 patients took at least 1 dose of open-label investigational product; 20 patients were randomized to receive double-blind treatment.
Participants were recruited over a 12 month period from April of 2011 to April of 2012 at 47 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Milnacipran | Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Period |
|
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|
| Placebo | Drug | matching placebo tablets daily |
|
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Forest Investigative Site 033 | Bullhead City | Arizona | 86442 | United States |
| Forest Investigative Site 012 | Fresno | California | 93710 | United States |
| Forest Investigative Site 045 | Fresno | California | 93720 | United States |
| Forest Investigative Site 051 | Fresno | California | 93721 | United States |
| Forest Investigative Site 035 | Orange | California | 92868 | United States |
| Forest Investigative Site 053 | Orange | California | 92868 | United States |
| Forest Investigative Site 050 | Sacramento | California | 95825 | United States |
| Forest Investigative Site 034 | Colorado Springs | Colorado | 80907 | United States |
| Forest Investigative Site 047 | Cromwell | Connecticut | 06416 | United States |
| Forest Investigative Site 061 | Gainesville | Florida | 32607 | United States |
| Forest Investigative Site 041 | Orange City | Florida | 32763 | United States |
| Forest Investigative Site 059 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 014 | Spring Hill | Florida | 34609 | United States |
| Forest Investigative Site 055 | West Palm Beach | Florida | 33409 | United States |
| Forest Investigative Site 058 | Blue Ridge | Georgia | 30513 | United States |
| Forest Investigative Site 031 | Savannah | Georgia | 31406 | United States |
| Forest Investigative Site 022 | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site 010 | Peoria | Illinois | 61614 | United States |
| Forest Investigative Site 005 | Indianapolis | Indiana | 46250 | United States |
| Forest Investigative Site 017 | Louisville | Kentucky | 40202 | United States |
| Forest Investigative Site 009 | Ann Arbor | Michigan | 48104 | United States |
| Forest Investigative Site 024 | Rochester Hills | Michigan | 48307 | United States |
| Forest Investigative Site 036 | Stevensville | Michigan | 49127 | United States |
| Forest Investigative Site 049 | Whitehouse Station | New Jersey | 08889 | United States |
| Forest Investigative Site 018 | Albuquerque | New Mexico | 87109 | United States |
| Forest Investigative Site 062 | Raleigh | North Carolina | 27612 | United States |
| Forest Investigative Site 052 | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site 038 | Akron | Ohio | 44308 | United States |
| Forest Investigative Site 016 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 015 | Dayton | Ohio | 45432 | United States |
| Forest Investigative Site 019 | Middleburg Heights | Ohio | 44130 | United States |
| Forest Investigative Site 001 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 027 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 066 | Mechanicsburg | Pennsylvania | 17055 | United States |
| Forest Investigative Site 054 | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative Site 046 | Greer | South Carolina | 29650 | United States |
| Forest Investigative Site 023 | Austin | Texas | 78732 | United States |
| Forest Investigative Site 003 | San Antonio | Texas | 78215 | United States |
| Forest Investigative Site 042 | San Antonio | Texas | 78258 | United States |
| Forest Investigative Site 025 | Clinton | Utah | 84015 | United States |
| Forest Investigative Site 013 | Salt Lake City | Utah | 84102 | United States |
| Forest Investigative Site 021 | Lynchburg | Virginia | 24503 | United States |
| Forest Investigative Site 006 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 063 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site 004 | Racine | Wisconsin | 53406 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Double-Blind Period |
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All demographic data was based on the Open-Label Safety Population, which consists of 116 patients who took at least 1 dose of open-label milnacipran.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label Milnacipran | Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined during the open label treatment phase. Oral administration, twice daily dosing |
| 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 |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | Participants |
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| 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 First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo. | During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances | The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients who were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat [ITT] Population). | Posted | Mean | Standard Deviation | Days | Change from Visit 7 (Week 8) to Visit 10 (Week 16) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Severity (PGIS) | The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill | The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat [ITT] Population). | Posted | Mean | Standard Deviation | units on a scale | Change from Visit 7 (Week 8) to Visit 10 (Week 16) |
|
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Adverse Event data was collected over a 17-month period from April, 2011 to September, 2012
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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 | Milnacipran - Open-Label Treatment Period | Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during a four-week dose escalation period, and then continued at the maximum tolerated dose for an additional four weeks. Oral administration, twice daily dosing | 0 | 116 | 62 | 116 | ||
| EG001 | Placebo - Double Blind-Treatment | Dose matched placebo, oral administration, twice daily dosing | 0 | 6 | 4 | 6 | ||
| EG002 | Milnacipran - Double-Blind Treatment Period | Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing | 1 | 14 | 6 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Noncardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (15.0) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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Due to the early termination of the study, no firm conclusions about the use of milnacipran in pediatric patients for the treatment of primary fibromyalgia can be drawn.
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 | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.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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| 15 years old |
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| 16 years old |
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| 17 years old |
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