Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Primary Fibromyalgia Clinical Trial

— MyFi  

Official title:

A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01331109
• Other study ID #: MLN-MD-29
• Status: Terminated
• Phase: Phase 2
• First received: March 31, 2011
• Last updated: July 31, 2013
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

Exclusion Criteria:

• Can not tolerate a minimum daily dose of 50mg milnacipran

• Significant risk of suicidality

• Pregnant or breastfeeding

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

Intervention

Drug:
• Milnacipran
maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Locations

Country	Name	City	State
United States	Forest Investigative Site 018	Albuquerque	New Mexico
United States	Forest Investigative Site 009	Ann Arbor	Michigan
United States	Forest Investigative Site 023	Austin	Texas
United States	Forest Investigative Site 040	Birmingham	Alabama
United States	Forest Investigative Site 058	Blue Ridge	Georgia
United States	Forest Investigative Site 033	Bullhead City	Arizona
United States	Forest Investigative Site 016	Cincinnati	Ohio
United States	Forest Investigative Site 025	Clinton	Utah
United States	Forest Investigative Site 034	Colorado Springs	Colorado
United States	Forest Investigative Site 015	Dayton	Ohio
United States	Forest Investigative Site 012	Fresno	California
United States	Forest Investigative Site 045	Fresno	California
United States	Forest Investigative Site 051	Fresno	California
United States	Forest Investigative Site 046	Greer	South Carolina
United States	Forest Investigative Site 017	Louisville	Kentucky
United States	Forest Investigative Site 035	Orange	California
United States	Forest Investigative Site 053	Orange	California
United States	Forest Investigative Site 010	Peoria	Illinois
United States	Forest Investigative Site 004	Racine	Wisconsin
United States	Forest Investigative Site 062	Raleigh	North Carolina
United States	Forest Investigative Site 024	Rochester Hills	Michigan
United States	Forest Investigative Site 050	Sacramento	California
United States	Forest Investigative Site 013	Salt Lake City	Utah
United States	Forest Investigative Site 003	San Antonio	Texas
United States	Forest Investigative Site 042	San Antonio	Texas
United States	Forest Investigative Site 063	Seattle	Washington
United States	Forest Investigative Site 014	Spring Hill	Florida
United States	Forest Investigative Site 036	Stevensville	Michigan
United States	Forest Investigative Site 055	West Palm Beach	Florida
United States	Forest Investigative Site 049	Whitehouse Station	New Jersey
United States	Forest Investigative Site 052	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Cypress Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)	Yes
Other	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: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)	Yes
Other	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: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)	Yes
Other	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: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)	Yes
Other	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: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)	Yes
Other	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: Preparatory acts or behavior; Aborted attempt; Interrupted attempt; Actual attempt; Completed suicide attempt	Baseline (Visit 1) to Week 53 (Visit 9)	Yes
Primary	Adverse Events	Number of Patients who experience one or more treatment emergent adverse event (TEAE)	Baseline (Visit 1) to Week 53 (Visit 9)	Yes