A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Overview
- Phase
- Phase 2
- Intervention
- Milnacipran
- Conditions
- Primary Fibromyalgia
- Sponsor
- Forest Laboratories
- Enrollment
- 116
- Locations
- 47
- Primary Endpoint
- Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility 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)
Arms & Interventions
Milnacipran
oral administration, twice daily dosing
Intervention: Milnacipran
Placebo
oral administration, twice daily dosing
Intervention: Placebo
Outcomes
Primary Outcomes
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances
Secondary Outcomes
- Patient Global Impression of Severity (PGIS)(Change from Visit 7 (Week 8) to Visit 10 (Week 16))