Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01328002 |
Recruitment Status :
Terminated
First Posted : April 4, 2011
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Fibromyalgia | Drug: Milnacipran Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia |
Actual Study Start Date : | April 30, 2011 |
Actual Primary Completion Date : | August 31, 2012 |
Actual Study Completion Date : | August 31, 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Milnacipran
oral administration, twice daily dosing
|
Drug: Milnacipran
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 Other Name: Savella |
Placebo Comparator: Placebo
oral administration, twice daily dosing
|
Drug: Placebo
matching placebo tablets daily |
- 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
- Patient Global Impression of Severity (PGIS) [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328002

Study Director: | Patricia M D'Astoli, LPN | Forest Laboratories |
Responsible Party: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT01328002 |
Other Study ID Numbers: |
MLN-MD-14 |
First Posted: | April 4, 2011 Key Record Dates |
Results First Posted: | May 14, 2019 |
Last Update Posted: | May 14, 2019 |
Last Verified: | March 2019 |
Fibromyalgia Pediatric Fibromyalgia Adolescent Fibromyalgia milnacipran Savella loss of therapeutic response |
Forest Research Institute Pain Fatigue Serotonin Norepinephrine Reuptake Inhibitors Randomized Withdrawal |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Levomilnacipran Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs |