Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Phase 2

Terminated

• Conditions: Primary Fibromyalgia
• Interventions: Drug: Placebo; Drug: Milnacipran

• Registration Number: NCT01328002
• Lead Sponsor: Forest Laboratories

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

Study Timeline

• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Study Start: 2011-04-30
• Primary Completion: 2012-08-31
• Study Completion: 2012-08-31
• Results First Submitted: 2013-08-21
• Status Verified: 2019-03
• Results First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Results First Posted: 2019-05-14
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	oral administration, twice daily dosing
Milnacipran	Milnacipran	oral administration, twice daily dosing

Primary Outcome Measures

Name	Time	Method
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.	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 Outcome Measures

Name	Time	Method
Patient Global Impression of Severity (PGIS)	Change from Visit 7 (Week 8) to Visit 10 (Week 16)	The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill

Trial Locations

Locations (47)

Forest Investigative Site 040; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 068; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 033; 🇺🇸 Bullhead City, Arizona, United States

Forest Investigative Site 012; 🇺🇸 Fresno, California, United States

Forest Investigative Site 045; 🇺🇸 Fresno, California, United States

Forest Investigative Site 051; 🇺🇸 Fresno, California, United States

Forest Investigative Site 035; 🇺🇸 Orange, California, United States

Forest Investigative Site 053; 🇺🇸 Orange, California, United States

Forest Investigative Site 050; 🇺🇸 Sacramento, California, United States

Forest Investigative Site 034; 🇺🇸 Colorado Springs, Colorado, United States

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