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

NCT ID: NCT01331109

Last Updated: 2013-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Fibromyalgia

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Milnacipran

oral administration, twice daily dosing

Group Type EXPERIMENTAL

Milnacipran

Intervention Type DRUG

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

Interventions

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Milnacipran

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cypress Bioscience, Inc.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia M D'Astoli, LPN

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 040

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 033

Bullhead City, Arizona, United States

Site Status

Forest Investigative Site 012

Fresno, California, United States

Site Status

Forest Investigative Site 045

Fresno, California, United States

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Forest Investigative Site 051

Fresno, California, United States

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Forest Investigative Site 035

Orange, California, United States

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Forest Investigative Site 053

Orange, California, United States

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Forest Investigative Site 050

Sacramento, California, United States

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Forest Investigative Site 034

Colorado Springs, Colorado, United States

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Forest Investigative Site 014

Spring Hill, Florida, United States

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Forest Investigative Site 055

West Palm Beach, Florida, United States

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Forest Investigative Site 058

Blue Ridge, Georgia, United States

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Forest Investigative Site 010

Peoria, Illinois, United States

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Forest Investigative Site 017

Louisville, Kentucky, United States

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Forest Investigative Site 009

Ann Arbor, Michigan, United States

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Forest Investigative Site 024

Rochester Hills, Michigan, United States

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Forest Investigative Site 036

Stevensville, Michigan, United States

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Forest Investigative Site 049

Whitehouse Station, New Jersey, United States

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Forest Investigative Site 018

Albuquerque, New Mexico, United States

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Forest Investigative Site 062

Raleigh, North Carolina, United States

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Forest Investigative Site 052

Winston-Salem, North Carolina, United States

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Forest Investigative Site 016

Cincinnati, Ohio, United States

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Forest Investigative Site 015

Dayton, Ohio, United States

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Forest Investigative Site 046

Greer, South Carolina, United States

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Forest Investigative Site 023

Austin, Texas, United States

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Forest Investigative Site 003

San Antonio, Texas, United States

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Forest Investigative Site 042

San Antonio, Texas, United States

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Forest Investigative Site 025

Clinton, Utah, United States

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Forest Investigative Site 013

Salt Lake City, Utah, United States

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Forest Investigative Site 063

Seattle, Washington, United States

Site Status

Forest Investigative Site 004

Racine, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26112278 (View on PubMed)

Other Identifiers

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MLN-MD-29

Identifier Type: -

Identifier Source: org_study_id