Overview

Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Status:
Terminated
Trial end date:
2012-08-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forest Laboratories
Collaborator:
Cypress Bioscience, Inc.
Treatments:
Levomilnacipran
Milnacipran
Criteria
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)