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Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

NCT01328002 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-05-14

Study results available
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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

Interventions

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

DRUG

Placebo

matching placebo tablets daily

Sponsors & Collaborators

  • Cypress Bioscience, Inc.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Patricia M D'Astoli, LPN · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328002 on ClinicalTrials.gov