Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cypress Bioscience, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milnacipran | Experimental | 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); for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Patients who experience one or more treatment emergent adverse event (TEAE) | Baseline (Visit 1) to Week 53 (Visit 9) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 033 |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Milnacipran | oral administration, twice daily dosing Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (Visit 1) to Week 53 (Visit 9) |
| Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| Baseline (Visit 1) to Week 53 (Visit 9) |
| Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| Baseline (Visit 1) to Week 53 (Visit 9) |
| Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| Baseline (Visit 1) to Week 53 (Visit 9) |
| Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| Baseline (Visit 1) to Week 53 (Visit 9) |
| Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:
| Baseline (Visit 1) to Week 53 (Visit 9) |
| 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 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 010 | Peoria | Illinois | 61614 | 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 016 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 015 | Dayton | Ohio | 45432 | 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 063 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site 004 | Racine | Wisconsin | 53406 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All demographic data was based on the safety population, which consists of 57 patients who took at least 1 dose of open-label milnacipran.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Milnacipran | oral administration, twice daily dosing Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks. |
| 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 |
| |||||||||||||||||||||||
| Maximum Tolerated Dose of Milnacipran | Maximum tolerated daily dose of milnacipran. | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
| |||||||||||||||||||||||||||
| Primary | Adverse Events | Number of Patients who experience one or more treatment emergent adverse event (TEAE) | 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:
| 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) | The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:
| 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population. | Posted | Number | participants | Baseline (Visit 1) to Week 53 (Visit 9) |
|
|
Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milnacipran | oral administration, twice daily dosing Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks. | 2 | 57 | 28 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedRDA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedRDA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedRDA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedRDA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedRDA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedRDA 15.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedRDA 15.0 | Systematic Assessment |
|
This study was terminated early, resulting in a small number of patients analyzed. Only descriptive statistics were presented.
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 | |
|---|---|---|---|---|
| Robert Palmer, MD | Forest Research Institute | 1-201-427-8200 | 8218 | robert.palmer@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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 15 years old |
|
| 16 years old |
|
| 17 years old |
|
| 75 mg |
|
| 100mg |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|