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

Forest Laboratories

Status and phase: Terminated; Phase 2

Conditions: Primary Fibromyalgia

Treatments: Drug: Milnacipran; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328002

MLN-MD-14

Details and patient eligibility

About

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.

Full description

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

Enrollment: 116 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary fibromyalgia
• 13-17 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

Milnacipran

Experimental group

Description:

oral administration, twice daily dosing

Treatment:

Drug: Milnacipran

Placebo

Placebo Comparator group

Description:

oral administration, twice daily dosing

Treatment:

Drug: Placebo