Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Primary Fibromyalgia Clinical Trial

— MyFi  

Official title:

A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01328002
• Other study ID #: MLN-MD-14
• Status: Terminated
• Phase: Phase 2
• Start date: April 30, 2011
• Est. completion date: August 31, 2012

Study information

• Verified date: March 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

• 8 weeks open-label treatment period with milnacipran.

• Followed by randomization to 8-weeks double blind treatment period for eligible patients

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: August 31, 2012
• Est. primary completion date: August 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of primary fibromyalgia

• 13-17 years of age

• To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale

• To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)

• To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)

• Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Exclusion Criteria:

• Severe psychiatric illness

• Severe renal impairment

• Evidence of active liver disease

• Pregnant or breastfeeding

• Significant risk of suicidality

• Unable, unwilling or inadvisable to discontinue prohibited medications

• History of alcohol abuse or drug abuse or dependence, within previous year

• Current systemic infection

• Autoimmune disease

• History of seizure disorder (other than febrile seizures)

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

Intervention

Drug:
• 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
• Placebo
matching placebo tablets daily

Locations

Country	Name	City	State
United States	Forest Investigative Site 038	Akron	Ohio
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 006	Bellevue	Washington
United States	Forest Investigative Site 040	Birmingham	Alabama
United States	Forest Investigative Site 068	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 022	Chicago	Illinois
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 047	Cromwell	Connecticut
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 061	Gainesville	Florida
United States	Forest Investigative Site 046	Greer	South Carolina
United States	Forest Investigative Site 005	Indianapolis	Indiana
United States	Forest Investigative Site 017	Louisville	Kentucky
United States	Forest Investigative Site 021	Lynchburg	Virginia
United States	Forest Investigative Site 066	Mechanicsburg	Pennsylvania
United States	Forest Investigative Site 019	Middleburg Heights	Ohio
United States	Forest Investigative Site 001	Oklahoma City	Oklahoma
United States	Forest Investigative Site 027	Oklahoma City	Oklahoma
United States	Forest Investigative Site 035	Orange	California
United States	Forest Investigative Site 053	Orange	California
United States	Forest Investigative Site 041	Orange City	Florida
United States	Forest Investigative Site 059	Orlando	Florida
United States	Forest Investigative Site 010	Peoria	Illinois
United States	Forest Investigative Site 054	Philadelphia	Pennsylvania
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 031	Savannah	Georgia
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
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	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	Change from Visit 7 (Week 8) to Visit 10 (Week 16)