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

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Forest Laboratories

Status and phase

Terminated
Phase 2

Conditions

Primary Fibromyalgia

Treatments

Drug: Milnacipran

Study type

Interventional

Funder types

Industry

Identifiers

NCT01331109
MLN-MD-29

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

Milnacipran
Experimental group
Description:
oral administration, twice daily dosing
Treatment:
Drug: Milnacipran

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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