Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
| Status: | Terminated |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 10/14/2017 |
| Start Date: | April 2011 |
| End Date: | August 2012 |
A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
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.
pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary
fibromyalgia.
- 8 weeks open-label milnacipran period
- Followed by randomization to 8-weeks double blind treatment period for eligible patients
- Followed by randomization to 8-weeks double blind treatment period for eligible patients
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
We found this trial at
30
sites
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