Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)

This study has been terminated.

Sponsor:

Collaborator:

Cypress Bioscience, Inc.

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01328002

First received: March 31, 2011

Last updated: August 23, 2012

Last verified: August 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Primary Fibromyalgia Syndrome	Drug: Milnacipran Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Milnacipran Levomilnacipran Milnacipran hydrochloride

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]

Secondary Outcome Measures:

Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]


Enrollment:	118
Study Start Date:	April 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Milnacipran oral administration, twice daily dosing	Drug: Milnacipran Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined at start of study; for 8 weeks Other Name: Savella
Placebo Comparator: Placebo oral administration, twice daily dosing	Drug: Placebo matching placebo tablets daily

Detailed Description:

8 weeks open-label milnacipran period
Followed by randomization to 8-weeks double blind treatment period for eligible patients

Eligibility


Ages Eligible for Study:	13 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of primary fibromyalgia
13-17 years of age

Exclusion Criteria:

Severe psychiatric illness
Severe renal impairment
Evidence of active liver disease
Pregnant or breastfeeding
Significant risk of suicidality
Unable, unwilling or unadvisable to discontinue prohibited medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328002

Show 35 Study Locations

Sponsors and Collaborators

Forest Laboratories

Cypress Bioscience, Inc.

Investigators


Study Director:	Patricia M D'Astoli, LPN	Forest Laboratories

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01328002 History of Changes
Other Study ID Numbers:	MLN-MD-14
Study First Received:	March 31, 2011
Last Updated:	August 23, 2012

Keywords provided by Forest Laboratories:


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

Additional relevant MeSH terms:


Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Antidepressive Agents Psychotropic Drugs	Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents

ClinicalTrials.gov processed this record on September 19, 2017

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