Phase 3
Completed N=1,025
Study of Milnacipran for the Treatment of Fibromyalgia
Source: ClinicalTrials.gov NCT00314249 ↗Enrolled (actual)
1,025
Serious AEs
1.7%
Results posted
Nov 2009
Primary outcomePrimary: Composite Syndrome Responder Status — 56; 103 Syndrome Responder Participants — p=<0.001
Summary
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Syndrome Responder Status |
56; 103 | <0.001 sig |
| PRIMARY Composite Pain Responder Status |
90; 147 | <0.001 sig |
| SECONDARY Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase |
48.0; 41.2 | — |
| SECONDARY Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. |
3.4; 2.9 | — |
| SECONDARY Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. |
-3.96; -5.50 | — |
| SECONDARY Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 |
36.4; 37.9 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
Exclusion Criteria
- psychiatric illness,
- depression,
- suicidal risk,
- substance abuse,
- pulmonary dysfunction,
- renal impairment,
- active cardiac disease,
- liver disease,
- autoimmune disease,
- cancer,
- inflammatory bowel disease
Data sourced from ClinicalTrials.gov (NCT00314249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.