Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Forest Laboratories
With
Cypress Bioscience, Inc.
* 8 weeks open-label treatment period with milnacipran.
* Followed by randomization to 8-weeks double blind treatment period for eligible patients
Age
13–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
Clareo Health | Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
