Conditions: Primary Fibromyalgia
Keywords: Fibromyalgia Pediatric Fibromyalgia Adolescent Fibromyalgia milnacipran Savella loss of therapeutic response Forest Research Institute Pain Fatigue Serotonin Norepinephrine Reuptake Inhibitors Randomized Withdrawal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

Brief 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.

Detailed description:
* 8 weeks open-label treatment period with milnacipran.
* Followed by randomization to 8-weeks double blind treatment period for eligible patients

Arms:
arm 1: oral administration, twice daily dosing arm 2: oral administration, twice daily dosing

Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: matching placebo tablets daily

Protocol document: