Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

NCT01328002 | Terminated Phase 2 Results DMC

• 1 other identifier: MLN-MD-14
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 47

Brief 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.

Conditions

Primary Fibromyalgia

Keywords

Fibromyalgia; Pediatric Fibromyalgia; Adolescent Fibromyalgia; milnacipran; Savella; loss of therapeutic response; Forest Research Institute; Pain; Fatigue; Serotonin Norepinephrine Reuptake Inhibitors; Randomized Withdrawal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Impression of Severity (PGIS)

  Change from Visit 7 (Week 8) to Visit 10 (Week 16)

Study Arms (2)

Milnacipran

EXPERIMENTAL

oral administration, twice daily dosing

Drug: Milnacipran

Placebo

PLACEBO COMPARATOR

oral administration, twice daily dosing

Drug: Placebo

Interventions

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

Also known as: Savella

Milnacipran

Placebo DRUG

matching placebo tablets daily

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of primary fibromyalgia
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Forest Laboratories: lead
• Cypress Bioscience, Inc.: collaborator

Study Sites (47)

Forest Investigative Site 040

Birmingham, Alabama, 35205, United States

Location

Forest Investigative Site 068

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 033

Bullhead City, Arizona, 86442, United States

Location

Forest Investigative Site 012

Fresno, California, 93710, United States

Location

Forest Investigative Site 045

Fresno, California, 93720, United States

Location

Forest Investigative Site 051

Fresno, California, 93721, United States

Location

Forest Investigative Site 035

Orange, California, 92868, United States

Location

Forest Investigative Site 053

Orange, California, 92868, United States

Location

Forest Investigative Site 050

Sacramento, California, 95825, United States

Location

Forest Investigative Site 034

Colorado Springs, Colorado, 80907, United States

Location

Forest Investigative Site 047

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 061

Gainesville, Florida, 32607, United States

Location

Forest Investigative Site 041

Orange City, Florida, 32763, United States

Location

Forest Investigative Site 059

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 014

Spring Hill, Florida, 34609, United States

Location

Forest Investigative Site 055

West Palm Beach, Florida, 33409, United States

Location

Forest Investigative Site 058

Blue Ridge, Georgia, 30513, United States

Location

Forest Investigative Site 031

Savannah, Georgia, 31406, United States

Location

Forest Investigative Site 022

Chicago, Illinois, 60634, United States

Location

Forest Investigative Site 010

Peoria, Illinois, 61614, United States

Location

Forest Investigative Site 005

Indianapolis, Indiana, 46250, United States

Location

Forest Investigative Site 017

Louisville, Kentucky, 40202, United States

Location

Forest Investigative Site 009

Ann Arbor, Michigan, 48104, United States

Location

Forest Investigative Site 024

Rochester Hills, Michigan, 48307, United States

Location

Forest Investigative Site 036

Stevensville, Michigan, 49127, United States

Location

Forest Investigative Site 049

Whitehouse Station, New Jersey, 08889, United States

Location

Forest Investigative Site 018

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 062

Raleigh, North Carolina, 27612, United States

Location

Forest Investigative Site 052

Winston-Salem, North Carolina, 27103, United States

Location

Forest Investigative Site 038

Akron, Ohio, 44308, United States

Location

Forest Investigative Site 016

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 015

Dayton, Ohio, 45432, United States

Location

Forest Investigative Site 019

Middleburg Heights, Ohio, 44130, United States

Location

Forest Investigative Site 001

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 027

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 066

Mechanicsburg, Pennsylvania, 17055, United States

Location

Forest Investigative Site 054

Philadelphia, Pennsylvania, 19139, United States

Location

Forest Investigative Site 046

Greer, South Carolina, 29650, United States

Location

Forest Investigative Site 023

Austin, Texas, 78732, United States

Location

Forest Investigative Site 003

San Antonio, Texas, 78215, United States

Location

Forest Investigative Site 042

San Antonio, Texas, 78258, United States

Location

Forest Investigative Site 025

Clinton, Utah, 84015, United States

Location

Forest Investigative Site 013

Salt Lake City, Utah, 84102, United States

Location

Forest Investigative Site 021

Lynchburg, Virginia, 24503, United States

Location

Forest Investigative Site 006

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 063

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 004

Racine, Wisconsin, 53406, United States

Location

Related Publications (1)

• 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.

  PMID: 26112278 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

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.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Patricia M D'Astoli, LPN

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: April 30, 2011
• Primary Completion: August 31, 2012
• Study Completion: August 31, 2012
• Last Updated: May 14, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-03

Locations

US (47)